Syneos Health

Updated: Yesterday Location: London, ENG, United Kingdom Job ID: 8930 You crave impactful and compelling communication. Role Overview The primary purpose of this role is to support the account team on the day-to-day running of our client accounts. This will include responsibilities such as timing plans, estimates, budget control, and assisting the trafficking of work through the creative services department. All the above will provide a solid grounding in servicing our clients' needs to a high level of excellence. Responsibilities Excel at tactical & admin processes & be able to train & oversee junior staff in this area Have established positive relationships with low and mid-level clients Build understanding of strategic, creative & digital planning & executions, including recognizing who and when to involve the appropriate experts within the team Support senior team members on research for pitches and new proposals Degree educated Good organizational and administration skills Strong communication skills Ability to work in a fast-paced environment Strong attention to detail and good proofreading skills Solution-focused - suggestion of ideas and recommendations where appropriate Ability to use PowerPoint, Microsoft Word, and Microsoft Excel At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Litmus Medical Communications acts as a catalyst to accelerate uptake and embed the value of therapies across the product lifecycle, bringing business strategy to science and scientific expertise to your business. With our base in Europe, we are cognizant of the diverse healthcare systems, regulations, and market dynamics of the region; however, we are not limited by geography and support our customers at a local, European, and global level. Whatever the reach required, we specialize in building relationships, understanding, and collaboration between the biopharmaceutical industry and medical/healthcare professionals. We develop a range of strategic solutions based on an understanding of both the objectives and issues of our customers as well as their stakeholders, focusing on facilitating peer-to-peer and scientific communications through a range of channels. As effective and compelling communication is key, whether for a marketing story, scientific data, or market access support, we have a dedicated editorial excellence team providing content that can be syndicated to deliver solutions to enhance patient care. Work Here Matters Everywhere How are you inspired to change lives? Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives around the world. Selecting us as an employer secures a career in which you're guaranteed to: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. To learn more about how we are shortening the distance from lab to life, visit Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: emailprotected . One of our staff members will work with you to provide alternate means to submit your application.

Updated: September 26, 2024 Location: London, ENG, United Kingdom Job ID: 5098 You're driven, resourceful, and above all else - remarkably smart. In this role, you will drive meaningful commercial success by securing profitable business, actively harvesting accounts, creating leads, and ensuring accurate project forecasting and pricing. The Managing Director will contribute to setting business direction, strategy, and priorities and take ownership for driving the overall growth and scalability of the Strategy, Product and Portfolio Consulting business. You will: Build positive working relationships with clients, consulting staff, managers, leadership, and internal support teams Achieve commercial success by actively harvesting accounts and creating leads at new accounts, soliciting support from other business units to close deals, and securing profitable business Develop and lead, independently, a large client book of business Achieve billable utilisation, led book of business, and sales targets, while collaborating with others to attain overall business objectives and metrics Lead and develop client relationships and ensure the delivery of well-structured projects that exceed client expectations. Take accountability for issues that may arise and rectify those issues. Deliver projects on time and on budget Minimum Requirements: MBA or a graduate degree in a life sciences field Leading Commercial / Strategic Consulting, with a focus on Commercial Strategy and product launch Known authority in marketing, portfolio and product valuation, market research and commercial strategy; able to leverage external network to improve profitable revenues and market positioning Recent experience working with large national and global pharmaceutical / biotech accounts Desired Requirements: Strong and demonstrable track record of successful life science consulting practice building A strong history of successfully selling, delivering and growing consulting revenues At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. To learn more about how we are shortening the distance from lab to life, visit Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: emailprotected One of our staff members will work with you to provide alternate means to submit your application.

Updated: August 21, 2024 Location: London, ENG, United Kingdom Job ID: 5117 You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and come out on top. In this role, you will be accountable for project management, team leadership, and business development. As a visible leader of the business, you will drive commercial success by securing profitable business, actively harvesting accounts, creating leads, and ensuring accurate project forecasting and pricing. You'll join the R&D Advisory Group within Syneos Health Consulting, where you will help make life science R&D organisations and operations more efficient and effective across research, clinical, regulatory, quality and pharmacovigilance. You will: Build relationships with customers, consulting staff, managers, leadership, and internal support teams Develop and lead a large customer book of business Oversee project budgets accordingly Be responsible for the design, efficiency, and outcomes related to customer projects Facilitate project team discussions to pressure test customer recommendations, underlying assumptions, and final deliverable quality Minimum Qualifications: MBA or a graduate degree in a life sciences field Demonstrated new business experience, from organic growth to RFI/RFP planning, development, and execution Experience across both promotional and non-promotional commercialisation activities Proficient in PowerPoint and Excel Ability to travel At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives around the world. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. To learn more about how we are Shortening the distance from lab to life, visit Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: emailprotected One of our staff members will work with you to provide alternate means to submit your application.

Managing Director, Medical Affairs Consulting Updated: November 6, 2024 Location: London, ENG, United Kingdom Job ID: 6049 You're driven, resourceful, and above all else - remarkably smart. In this role, you will demonstrate your experience as a thought leader in the biopharmaceutical industry and be a trusted advisor. Viewed as a key senior leader within the consulting business, the Managing Director drives meaningful commercial success by securing profitable business, actively harvesting accounts, creating leads, and ensuring accurate project forecasting and pricing. As part of the Consulting leadership team, the Managing Director - Medical Affairs will contribute to setting business direction, strategy, and priorities and take ownership for driving the overall growth and scalability of the Medical Affairs consulting business. You will: Build positive working relationships with customers, consulting staff, managers, leadership, and internal support teams. Develop and lead, independently, a large customer book of business. Support the development of a healthy Advisory Group and overall Consulting business unit, beyond individual contributions of sales and book of business. Achieve billable utilization, lead book of business, and sales targets, while collaborating with others to attain overall business objectives and metrics. Hold an MBA or a graduate degree in a life sciences field. Be a known authority in medical affairs commercial strategy; able to leverage external network to improve profitable revenues and market positioning. Have a strong history of successfully selling, delivering, and growing consulting revenues. At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. We will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives around the world. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. To learn more about how we are shortening the distance from lab to life, visit . Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: emailprotected . One of our staff members will work with you to provide alternate means to submit your application.

QC Senior Sponsor Contracts Manager Summary: Manages Quality Control of all client deliverables within the Global Deal and Contract Management (GDCM) group. Guarantees high quality of departmental output through detailed review of both contract documentation and study budgets. Ensures all deliverables conform to both client expectations and audit requirements. Provides detailed and constructive feedback to internal stakeholders and works with them to refine contractual materials. Tracks adherence to company processes and provides regular performance feedback. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities : Analytically reviews the more complex budget tools and contractual materials from a Syneos Health, client and audit perspective to ensure the highest possible quality of output. Proactively works with contract analysts to refine deliverables in accordance with existing QC checklists and company policies. Evaluates all budget commentary to ensure a clear, concise and robust narrative. Assesses validity of study pricing and suitability of budgets prior to client delivery. Ensures consistency between pricing tools, budget grids, payment schedules and all contractual documentation. Utilizes QC checklists to perform a thorough review of Change Order, Change Notification Form and Ballpark documentation to ensure quality and consistency. Ensures all legal entities and defined terms are correct, appropriate and applied consistently throughout documents. Validates the presence and accuracy of inflation language if applicable. Maintains a high level of flexibility and adaptability. Proactively creates and revises priorities as the need arises whilst working toward standard cycle times of review. Supports the Change Order process through expeditious reviews and the provision of concise feedback. Identifies and raises issues before they become critical and adjusts quickly to the changes of a dynamic organization. Ensures adherence to Contract Management systems by reviewing records during the QC process. Reviews these systems to drive compliance with both GDCM and Syneos Health reporting processes and approval policies. Evaluates the performance of analysts within the GDCM group by assessing the quality of materials submitted for QC and providing performance feedback on a monthly basis. Assists with ownership of this performance report as needed. Updates and maintains departmental template and process documents. Leads QC training for the Client Contracting Solutions group as needed. Assists with audit inquiries as needed. Mentors members of the QC team as needed. Performs other duties as assigned. What we're looking for: BA/BS degree in a Business Administration or Finance with a minimum of 7 years' experience preferably in budgeting, finance, proposal development and/or contracts management within a clinical research/pharmaceutical environment; or equivalent combination of education, training and experience. Flexibility in responding to job demands. Have excellent problems solving skills and outstanding attention to detail. Ability to perform several tasks simultaneously to meet critical deadlines and possess strong analytical skills. Knowledge of Microsoft Excel, Word and understanding of costing models. Ability to review and interpret budgets. Ability to work successfully in a team environment and maintain effective working relationships with colleagues and manager. Demonstrates effective time management skills. Ability to prioritize multiple tasks with management guidance and oversight. Excellent interpersonal, verbal and written communication skills. Demonstrates a positive and flexible attitude toward new and/or unconventional work assignments. Ability to consistently perform and deliver a high quality work product. Excellent organizational skills. Ability to work well under pressure and adapt to changing priorities. Knowledge of clinical trial proposal process and budget management. Professional ability to interact with individuals at all levels and different personalities. Proficiency in mathematics, written language and ability to work with both budgets and text. Good interpersonal skills and ability to work well with others. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Manager, Biostatistics - FSP team Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. • Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. • May be responsible for leading or participating in projects across multiple studies or programs. • May support business development activities. • May participate in, or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required. What we're looking for • Graduate degree, or equivalent, in biostatistics or related discipline. • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. • Previous management experience or demonstrated leadership ability preferred. • Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. • Experience with regulatory submissions preferred. • Ability to read, write, speak, and understand English. • Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. JOB RESPONSIBILITIES Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. QUALIFICATION REQUIREMENTS Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."

Associate Project Director - General Medicine Come discover what our 25,000+ employees already know: work here matters everywhere . We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Equal Opportunities Plan . Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions. Job responsibilities; Project Leadership and Delivery : Manages a project as a Project Manager overseeing interdisciplinary clinical research studies and/or programs and ensures compliance with GCP, relevant SOP's and regulatory requirements. Acts as primary liaison and/or facilitator between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement. Leads project team to ensure quality, timelines and budget management. Implements resource strategies to achieve project goals. Accountable for all project deliverables for assigned projects. Develops contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Identifies and implements performance improvement and operational efficiencies. Reporting and Communication : Maintains and evaluates project progress by maintaining timelines, project plans and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports as well as functional area plan to customers, appropriate team members and senior management. Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication. Attends and presents information at internal and external project meetings. Business Development : Develops strong relationships with current and prospective clients to generate new and/or add-on business for the future. Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. and presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings. Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract. Project Administration : Responsible for quality and completeness of TMF for assigned projects. Accountable for the financial performance of each project assignment. Accountable for all project deliverables for each project assigned. Accountable for maintenance of study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of the study conduct. Therapeutic Mastery : Demonstrates mastery of current business unit therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. Management : Serves as team leader and line manages and mentors other project management and clinical monitoring staff. Facilitates team building and communication. Ability to successfully deliver a project through successful delegation and oversight of project and functional leads. What we're looking for; Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. Ideally Project Management qualified i.e. Prince II or PMP / equivalent. Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures. Strong organizational and time management skills. Clinical research organization (CRO) and relevant therapeutic experience preferred Ability to embrace new technologies. Excellent communication, presentation, and interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. Ability to travel as necessary (approximately 25%). Get to know Syneos Health; We are the only full-service biopharmaceutical solutions company in the world . That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information; Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.

Associate Director, Site Patient Access Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Responsible for the financial management for their assigned portfolio of projects • Oversees Site and Patient Access Managers and senior staff in delivery of department objectives. Maintains metrics to ensure accountability to budgets, timelines, and deliverables, for site and Patient Access activities • Drives Site and Patient Access BU level initiatives in their assigned area by working with internal and external stakeholders. • Oversees assigned portfolio of projects or areas of responsibility and maintains metrics to ensure accountability to budgets, timelines, and deliverables, for Site and Patient Access activities. • Supports efforts to define, develop, and implement standards and procedures for the Site and Patient Access program with Site and Patient Access Leadership; evaluates processes and services against those standards to enable delivery and meet performance targets for Site and Patient Access • Strong leadership skills; ability to teach/mentor team members. Ability to coach employees to reach performance objectives. Ability to recognize and take appropriate action when employee performance is not acceptable. What we're looking for • Bachelor's Degree • Post Graduate Degree Preferred • Extensive experience in clinical trial delivery including but not limited to; applicable regulations, drug development, & clinical project management, experience in managing teams of clinical research employees locally and globally • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet • Strong organizational, interpersonal, and team-oriented skills • Excellent verbal, written, communication and time management skills • Ability to perform several tasks simultaneously to meet deadlines in a dynamic environment • Ability to be flexible, adapt to change, as well as work as part of a team in a matrix environment under close supervision. Must be flexible around travel and work hours if a business need should arise. Travel up to 25% Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Project Director / Sr Project Director, Delivery - GenMed, EMEA based role Come discover what our 25,000+ employees already know: work here matters everywhere . We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Equal Opportunities Plan . Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions. Job responsibilities; Provides oversight for all assigned projects to ensure study launch, conduct and closeout occur according to the Customer's and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations. Forecasts, prioritizes, and directs staff to achieve on-time sponsor deliverables with quality and in accordance with contracted scope and Customer expectations Collaborates with Therapeutic Strategy and Innovation team to provide operational input in support of proposal development and pricing-including the proposed operational strategy Drives preparation and facilitation of bid defense meetings in collaboration with Therapeutic Strategy and Innovation team and Business Development Provides oversight to project management teams in driving management of financial aspects of assigned projects-i.e., executed contracts, CNFs, change orders, forecasting, invoicing, etc. Actively mentors Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks. As necessary, troubleshoots difficulties which may arise in project conduct between the company and Customer and manages escalations appropriately. Facilitates team building and communication. Acts as a liaison and facilitator between other functional areas for overall operational issues. Develops and maintains knowledge of evolving trends related to therapeutic area, competitive landscape (e.g., standard of care) and drug development trends Provides support to teams in regularly and comprehensively assessing and mitigating risks on their projects to assure patient safety, data integrity and quality project delivery Participates in corporate initiatives and/or represents Project Management in regional or business activities. Participates in the project Risk Review meeting process. Liaises with Project Sponsors and teams to promote optimized application of project management disciplines and approaches within a fast-paced, high-tech environment Shares lessons learned and best practices across programs, building relationships with key stakeholder's cross-functionally, across all levels Supports Change Management, including adjustments based on emerging business or technical opportunities and challenges Maintains senior management-level relationships with Customers via routine meetings (e.g., 1:1's with counterparts), governance meetings and other forums What we're looking for; Requires a BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company Prior cross-functional project management experience within the clinical trial industry is required Pharma/CRO experience is required, to include client relationship management Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary Must have demonstrated proficiency with ICH/GCP guidelines Proficiency in Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint, etc.) Demonstrated ability to manage multiple tasks within a dynamic projectized matrix team environment is essential - all while assuring project delivery on time and with quality Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach Vaccines experience required. Prior experience in a similar role. Get to know Syneos Health; We are the only full-service biopharmaceutical solutions company in the world . That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information; Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.

Site Contracts Specialist / Lead - Sponsor Dedicated Based in the UK - Hybrid Working (Home-based and office-based in Uxbridge, London) Come discover what out 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number. They're our family, friends and neighbors. Why Syneos Health? means we're committed to our Total Self Culture - where everyone can authentically be themselves. Our Total Self Culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct results of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures and perspectives - we're able to create a place where everyone feels like they belong. The Role: With supervision, conduct activities associated with the development and negotiation of site contracts, including company sponsored and investigator sponsored clinical site contracts, non-clinical contracts, confidentiality disclosure agreements, and cooperative research agreements. Job Responsibilities: Negotiate site study agreements and amendments with limited supervision Participate as part of the Global Study Teams (Master Clinical Study Agreements, Clinical Study Agreements and ancillary site agreements) with the appointed CRO or affiliate, or directly with the site as appropriate with limited supervision Escalate to the appropriate colleague when a significant risk to the business is identified Collaboration with Grant Manager, to ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs. Inform key stakeholders on cycle time intelligence and engage early on in the feasibility process when requested Attend study team meetings Track and measure project and team timelines and progress of site contracting through collection of cycle time metrics Use metrics with CRO's and affiliates to identify, manage milestones and risks and appropriate escalation on site contracting Identify potential risks and manage issue resolution with management oversight Ensures status reports are provided to appropriate parties both internally and externally on a regular basis Manage escalations as appropriate and highlight to senior management for direction Evaluate changes requested within contracts and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback, whenever possible, to facilitate the review Comply with audit requests and support to any inspection actions as requested Actively participate to cross functional regional or global projects Participate and support moderately complex department specific initiatives and projects Ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs Contribute to strategy and new processes, identify new best practices, and contribute to continuous improvement Requires limited supervision Interact with internal and external customers Capitalize on strengths of relationships/networks to effectively work with cross functional teams Performs other work-related duties as assigned. Minimal travel may be required (up to 25%) What we're looking for: BS degree in life sciences, a health related field, or equivalent combination of education and experience. Significant experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience. Thorough knowledge of applicable regulations, GCP, drug development and clinical project management procedures. Working knowledge of clinical site contract negotiations and contract terms and conditions Basic knowledge of financial terms Competent computer skills Ability to work as part of a team as well as on an individual basis Strong organizational skills with the ability to multi-task Problem solving skills with a commitment to delivering quality work in a deadline-driven environment Fluency in English languages (written, spoken) Right to work and live in the UK Ability to work partially office based in Uxbridge (sponsor based) 2-3 days per week Get to know Syneos Health: We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

in-house CRA, Clinical Operations Specialist - Sponsor-dedicated home - based ocassional travel with CRA Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities One per study/one per region Actively contribute to site audit readiness through back-up activities with the primary site CRA, including but not limited to: periodic eTMF review, collection of documents from the site, escalation of identified issues, CTMS up-to-date, etc. Collect and review site essential documents and update Regulatory Document Tracker Send reminders and/or CTMS reports to CRAs re: open follow up items, protocol deviations, and quality issues Support CRAs to ensure all site supplies are available on site for site initiation visits Support requests from CRAs while they are onsite (document retrieval, vendor questions) Support site training documentation collection and tracking of training documentation Support in maintaining compliance of sponsor systems i.e., CTMS, TMF, Trifecta, etc. Follow-up on outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites Undertake project related admin tasks to support the Lead CRA, i.e., meeting minutes, tracking, site document preparation May attend clinical trial site co-monitoring visits to support clinical trial activities such as ISF/eTMF reconciliation and audit preparation, as needed. Attends Investigator Meetings and study-specific training for assigned trials What we're looking for CTA backgrond or similar Min 12 months of clinical research experience Good understanding of study documentation Ability to work collaboratively Good communication and interpersonal skills Ability to embrace new technologies Ability to ocassional travel together with CRA Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. - MB2

Senior Spotfire Developer Discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. JOB SUMMARY Serves as lead Spotfire Clinical Programmer to manage and support all functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverable whilst leading less experienced programmers. Designs, writes, validates, and maintains software to meet specifications. As senior technical subject matter expert, supports internal and external customers for assigned tools including but not limited to Spotfire, R and Python scripts within Spotfire, file transfer automation tools, and occasional use of other data manipulation/analysis languages such as SQL, HQL, and SAS. Proactively monitors applications for performance and/or system errors. Manages external application vendor issues, integrations, and implementations. JOB RESPONSIBILITIES Utilizes assigned development tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. Create complex Spotfire Dashboards or Reports Using Tibco Spotfire. Develop cross table, Bar chart, Tree map and complex reports which involves Property Controls, Custom Expressions, and scripting. Develop specifications for visualizing CRF data sets such as routine listings, tables and figures. Receive and process external data, and validate data sets, tables, listings, and figures. Create data visualizations (Tables/Graphs) in SPOTFIRE based on ad-hoc requirements. Move visualizations to production through development stages per existing process Collaboratively engage clinical scientists, medical reviewers, and other professionals to provide compelling and efficient data review capabilities Review selected panels and rules for design and usability, and also to prevent storage, reporting or standards issues. Authors and maintains all required documentation, including the development of specifications, programs, validation and UAT efforts in support of Spotfire products development, import setup and processing, export setup and processing, listings, and custom reports. Serves on project teams to coordinate and lead development activities for Spotfire clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. Reviews and provide input on study budgets and monitors scope of assigned work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Possesses and maintains a broad overall knowledge in the fields of data analytics, clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. QUALIFICATION REQUIREMENTS Bachelor's degree, Master's degree preferred, In lieu of Bachelor's degree, equivalent related education and experience. Preferred experience using Spotfire for analysis of clinical data of 5+ years Minimum experience in Spotfire Programmer Role for more than 3+ years - experience using similar data analytics platforms may be considered Preferred experience analyzing data from Medidata RAVE EDC of 1+ years (other EDC systems may also be considered) Ability to deal effectively with sponsors and internal customers at all levels. Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. SUMMARY OF RELEVANT SKILLS Spotfire 10.x and later Python for automation within Spotfire R scripting for data enrichment and analysis within Spotfire Analysis of clinical data sets (CRFs, labs, etc.) Data acquisition planning Merging data from multiple sources SAS programming including data analytics Query languages such as SQL, HQL, Spark Gathering analytics requirements and designing visualizations User interface design and configuration using DHTML, JavaScript, and CSS Spotfire administration and architecture Clinical Database design and programming (such as Rave EDC) Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."

*Statistical Programmer II - Single Sponsor Dedicated* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management. • May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Assists with the transfer of deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required. *What we're looking for* • Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. • Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. • Proficiency in ADaM / SDTM and TFLs. • Excellent written and verbal communication skills. • Ability to read, write, speak, and understand English. *Equal Opportunities Plan*. Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions. #LI-JZ1 *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

*Senior Statistical Programmer - EUROPE - Single Sponsor!* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required *Preference will be given to those from previously disadvantaged groups that meet the minimum requirements of the position**What we're looking for* • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive experience with ADaM / SDTM / TFLs • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. *Equal Opportunities Plan*. Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions. #LI-JZ1

*Principal Auditor, QA* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * General Profile Syneos Health Audits • Plans and conducts assigned audits. • Performs For Cause audits as needed. • Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management. • Reviews responses to audit findings for appropriateness and completeness. • Closes assigned audits. Customer Audits/Inspections • Prepares for and hosts or supports customer audits. • Prepares for and hosts or supports Regulatory Authority Inspections. Other • Serves as Lead Auditor on team-based Syneos Health audits. • Serves as a trainer and mentor to less experienced QA Auditors. • Provides guidance and training to operational staff on quality related matters. • Writes, reviews or revises QA SOPs/WIs Complexity • Applies critical thinking to identify solutions to non-standard requests and complex problems. Supervision • Requires minimal instructions on day-to-day work and new assignments. Other tasks • May review audit reports of peers. • May provide coaching and training to company personnel on quality-related matters. • Participates in local and / or company-wide special projects according to his / her skills or talents and the needs of the organization. • Involves himself / herself in appropriate industry associations and other relevant forums. • Performs other work-related duties as assigned. • Moderate travel may be required (up to 50%).*What we're looking for* • Requires a Bachelor's degree in the science/health care field or equivalent with significant experience and expertise in various aspects of GxP quality assurance auditing. • Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting and laboratories) is essential. • Excellent knowledge of GxP regulatory requirements. • Knowledge of Medical and technical terminology related to the audit types to be conducted. • Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency). • Able to handle multiple tasks to meet timelines in dynamic environment. • Strong organizational, presentation and interpersonal skills. • Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds. • Ability to negotiate and provide constructive feedback. • Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation. *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #LI-AM1

* JOB SUMMARY * Assists and directs the customer-focused leadership and management of Regulatory Advice and Delivery Site Start-Up (RAD SSU) deliverables within the assigned projects or programs. Directs the technical and operational aspects of the RAD deliverables of the assigned projects. Accountable for the delivery of the post award early regulatory guidance and the regulatory impact assessment during study maintenance on time, on budget, and in compliance with all applicable regulations. Responsible for performing and overseeing core regulatory activities (such as core compilation and review of documents, and core submissions) related to submission from Site Start-Up activities until study end. Develops integrated RAD timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor. May act as the Regulatory Subject Matter Expert (SME) or as a mentor for less experienced staff. Assists senior RAD management for the SSU regulatory intelligence maintenance such as medical device and/or GMO regulation data mining in local country regulation, regulatory trainings support to the business departments. * JOB RESPONSIBLITIES * * Effectively manage the RAD resources including oversight of all project RAD deliverables which encompasses all activities from early post award regulatory guidance to study end * Develops new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities. Maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assess client needs. * Reviews the project RAD budget with the functional leads, project PM, and the SSU Business Unit Controller against SOW, project milestones and budget to ensure project profitability. Eventually takes corrective measures where necessary to keep project activities in line with budget and gross profit expectations. * Accountable in parallel to lead and provide adapted oversight regulatory activities for projects having high complex regulatory profile as Operational Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management) * * * * Deliver overall RAD strategy driven by an operational risk management approach and status at client meetings and communicates outcomes to project team. Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessment. * Develops and manages integrated RAD timelines and reports weekly progress including plans (to address potential timing risks/gaps or project regulatory KPI's) that track project's regulatory quality, delivery and predictability * * * * Monitor and ensure team's accountability, efficiency and adherence to project timelines. Ensure quality of designated deliverables. Responsible for driving team efficiencies with a goal of reducing waste and increasing RAD predictability. Accountable for individual utilization metrics. * * * * Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Identify skills and abilities that allow a regulatory professional to represent the function effectively as a member of a multi-disciplinary team. Support team with proposal development and client pitches (where applicable). * * Approves courses of action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling * * * Pro-actively supports RAD intelligence strategies and communications * Identify and interpret laws, regulations, and guidance documents for domestic and international agencies relevant to the development and commercialisation of healthcare products. Identify new regulatory trends that could affect future requirements * Evaluate the global healthcare environment and its potential impact on the organisation. * Develop Regulatory Intelligence Programs on specific regulatory complex topics. Monitor team adherence for the timely follow-up for SSU operational Regulatory Intelligence Maintenance. Maintain current knowledge of applicable regulations and guidelines and direct implementation of training, as necessary. * Develop negotiation strategies with regulatory agencies and/or the regulated industry * Develop leadership skills and presentations that inspire high performance within the regulatory environment.at team or departmental review meetings. Have oversight of training programs for appropriate Syneos departmental teams. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. and explain the importance of adapting to the changing regulatory environment * * * * Designated as subject matter expert in specific regulatory areas (e.g. pediatric studies, advanced therapy products, medical devices, etc.) to author and review Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes * Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals * Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products * Explain the role of RAD professionals, their interrelationships with other functions in the organization and the importance of working as a team and operate effectively as a member of a multi-disciplinary team * Prioritise work to meet timelines and use a systematic approach to accomplish assigned tasks. *Other Responsibilities:* * Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. * Ability to travel as required - approximatelly 40% * Minimum of a BA or BS * Minimum of seven (7) years' experience working in a Clinical Research environment with a minimum of five (5) years regulatory experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities do the job. Minimum of two (2) years of management experience * Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non- interventional studies, clinical trial and medical device regulations) with extensive clinical trial experience * Experience in working to applicable GxPs (e.g GVP, GCP, ISO 14155) etc * Strong CRO operational experience with a track record in project management working in an international or global capacity. * Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. * Previous experience in budgeting and quality management * Excellence communication and interpersonal skills, both written and spoken, with an ability to influence, convince and persuade * Strong leadership skills; ability to teach/mentor team members * Ability to recognize and take appropriate action when employee performance is not acceptable * Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet. * Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

* JOB SUMMARY * Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. F irst level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. * * * JOB RESPONSIBILITIES * * Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. * Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. * Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. * Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports * Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. * Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. * Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. * Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. * Performs system integration activities, application updates, and user acceptance testing. * Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. * Assists in project meetings and actively contributes and participates in departmental review meetings. * Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. * Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. * Manages project resources, proactively alerting management of delivery and resourcing needs. * Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meeting, etc; *QUALIFICATION REQUIREMENTS * * Bachelor's degree preferred, or equivalent combination of related education and experience. * The ability to deal effectively with sponsors and internal customers at all levels. * Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. * Demonstrated experience in managing multiple priorities in a highly dynamic environment * Experience working in a matrix-structured environment is preferred * Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail * Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. * Ability to travel as necessary (up to 25%) This job excludes Colorado applicants. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

*Sr. or Principal Statistical Programmer - FSP* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities* • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required*What we're looking for* • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

* JOB SUMMARY * Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. F irst level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. * * * JOB RESPONSIBILITIES * * Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. * Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. * Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. * Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports * Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. * Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. * Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. * Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. * Performs system integration activities, application updates, and user acceptance testing. * Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. * Assists in project meetings and actively contributes and participates in departmental review meetings. * Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. * Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. * Manages project resources, proactively alerting management of delivery and resourcing needs. * Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. *QUALIFICATION REQUIREMENTS * * Bachelor's degree preferred, or equivalent combination of related education and experience. * The ability to deal effectively with sponsors and internal customers at all levels. * Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. * Demonstrated experience in managing multiple priorities in a highly dynamic environment * Experience working in a matrix-structured environment is preferred * Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail * Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. * Ability to travel as necessary (up to 25%) This job excludes Colorado applicants. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. #LI-AN1