Parexel

Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally! We currently have TWO tremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to expand professionally, do more than a narrow scope of work, work alongside a large team of CPMS experts, and provide solutions to a variety of clients with various products in different stages of development across multiple therapeutic areas, we would love to connect! We are currently seeking a highly experienced and highly innovative Director, Clinical Pharmacology Modeling and Simulation (CPMS) and an Associate Director, CPMS to join our team and help our clients reduce the time to bring new treatments to patients. The Scientific Associate/Director provides leadership to ensure the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development. They contribute to the strategic direction and goals of the function and may champion or lead department objectives/initiatives. The Scientific Director is recognized for and provides scientific leadership in CPMS, working closely with the client to develop and implement strategies to support drug discovery and development programs. The Scientific Director leads client projects and is accountable for end-to-end delivery and quality review of all client projects under their leadership. They provide guidance on development of new service lines and provide subject matter expertise to capability development projects within the department and across the integrated Parexel organization. Key Accountabilities: Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of PK data from clinical trials covering all phases of drug development Analyze clinical PK data as a member of multidisciplinary development teams. Work with clinical teams to design PK/PD components in various study designs such as first-in-human, Proof of Concept, Phase 2B, bioequivalence and drug-drug interaction studies. Responsible for the strategic and operational delivery of client programs and projects to timelines, quality expectations and regulatory requirements. Act as a mentor to less experienced departmental members Qualifications: Depth of experience and relevant experience will determine level of role, Associate Director level role or Director level Excellent written and verbal English communication skills are required. Chinese language skills are a plus Advanced science degree (PhD, PharmD, MSc) and/or relevant experience Significant experience in clinical drug development of both NCEs and biologicals Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations Experience using Phoenix WinNonlin to conduct non-compartmental and compartmental analysis Experience using other software such as NONMEM, GastroPlus or R are desirable Strong non-compartmental analysis experience Previous popPK and/or PBPK experience are a plus Excellent interpersonal, verbal and written communication skills Extensive clinical/scientific writing skills Client focused approach to work ethic Exhibits and promotes a flexible attitude with respect to work assignments and new learning Ability to direct and manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value and promote the importance of teamwork. Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations Knowledge And Experience Significant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired Acknowledged as an expert in the industry Demonstrated knowledge of regulatory environment as it relates to CPMS and Drug Development

We are looking for Regulatory Affairs CTA Professionals on various levelsto join our client dedicated project. In this role you will be responsible for managing and submitting the dossier to those competent authorities. The role can be either remote or office based and we have flexibility in a location (UK, EU countries) Role responsibilities: Works within a team environment or individually based on the project needs Works within broad project guidelines and facilitates issue and conflict resolutions developments/improvements - Demonstrates the use of the organization's consulting models and methodologies and uses experience to suggest possible Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction Meets established metrics as specified in scorecard on an annual basis Experience and Skills required for the role: University degree Strong experience working in a CRO industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus Previous experience of managing and submitting marketing authorization dossiers in varius European countries Previous CTA submission knowledge is essential Client-focused approach to work Project leadership and management knowledge Good communication and presentation skills Fluency in English written and spoken

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the peopleWith Heart . Parexel has an exciting opportunity for an experienced Senior Site Feasibility Liaison (Snr SFL) this is a critical role for the delivery of Parexel studies and setting up a trial for success. The Snr SFL must demonstrate strong communication skills to build effective relationships with Investigators and research sites and will champion Parexel within their region. Senior Site Feasibility Liaison will also provide broader country/region expertise based on operational and clinical landscape knowledge. The Snr SLF will be a local clinical expert to represent their country/region and will be the advocate for their region to ensure it is included in the Parexel portfolio and support new business opportunities by helping to gather critical data to support client meetings or deliverables. An expert in terms of local infrastructure, standards of care, healthcare trends and guidelines. Working in conjunction with site intelligence and site alliance teams, will work to improve the knowledge that we have on clinical research teams and facilities including owning the quality of information within the Investigator Intelligence Platform that pertains to their country, region or therapeutic area. Key Accountabilities: Responsible for the review draft site lists, communicate with sites to ensure high response rates, co-ordinate CDA collection and query inconsistent/incomplete survey information, provide data-driven recommendations with regards to site selection Conduct phone interviews/follow-up with Investigators or site personnel to discuss standard of care, trends, patient barriers, protocol design considerations Support the central feasibility teams with local insight to support country strategy, protocol development and new business awards. Provide accurate, timely and realistic information. Proactively work to understand healthcare re-imbursement, trial infrastructure, patient motivations, patient support groups, site networks, new potential sites/Investigators for consideration in your country, region, therapy area Understand, communicate, and help to mitigate the risks to delivery for your country, region, therapy area Proactively work to ensure accuracy of critical information held in the Investigator Intelligence Platform relevant to your country, region or therapy area. Work to build out valuable profile information for key sites to improve efficiency and improve the site experience Actively work with clinical and medical experts in your country to promote collaboration and to facilitate information gathering. Work closely with central feasibility counterparts to ensure a common understanding of risk and to promote the consideration of your country or region in future trials. Develop and maintain collaborative relationships with Investigators and site personnel. Promote a culture of innovation and respect with the patient first and foremost. Provide broader country/region expertise based on operational and clinical landscape knowledge. Knowledge/Skills: Several years Pharmaceutical/CRO Industry experience in Clinical Research. Wealth of experience in clinical management/feasibility management of global clinical trials with significant local clinical experience. Able to demonstrate understanding and experience in selecting and starting up clinical trial sites. Autonomous, driven, takes pride in quality of work, attention to detail. Ability to build effective relationships with others (Investigators, research teams. Independent thinker and fast leaner. Exceptional analytical and problem-solving skills. Effective interpersonal, presentation, oral and written communication skills. Capability to work in a matrix environment and to value the importance of teamwork. Ability to manage multiple tasks, to be flexible and to prioritize. Strong client focus - sense of urgency to respond to client requests. Strong computer skills. Education: Degree / further degree Scientific/Medical/Nursing background preferred Language skills: Fluent in English, oral and written Fluent in local language, as applicable Other language skills beneficial This is a homebased position

Job Description Our Statistical Programming teams are not only focused on delivering quality results for our client's needs, but also value working with one another in a flexible environment. Although some team members are home-based and others are office-based, our virtual resources support our teams to work collaboratively and effectively across the globe. The overall long tenure of our team integrates a depth of knowledge and experience. Working together, you will create paths to answers and contribute to new therapies which ultimately will impact the patient. What you'll do: The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects. Qualifications On your first day we'll expect you to have: University degree level in a relevant discipline and/or equivalent work experience. Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Ability to successfully work as part of a global team. Effective time management in order to meet daily metrics or team objectives. Competent in written and oral English. Good communication skills. A little about us: Parexel is proud to be a leading Clinical Research Organization, with colleagues committed to make a difference. As a member of our global team, you'll have discussions in an open environment-sharing expertise, promoting learning, and getting to know one another on a personal level. You'll also experience supportive management that encourages career growth through consistent performance discussions and evaluations. Why Work at Parexel There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* *A Senior Consultant * * provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. * serves either as an individual contributor, a workstream lead or provides overall project leadership. * provides guidance to project team members on technical/process issues. *Key Duties:-* • Coordinate a project team of analysts to ensure timely delivery of projects to a high standard, managing client communications, and ensuring projects are delivered on budget. Including project planning and execution. • Coordinate real-world data collection processes from sites and data register. • Lead client engagements activities. To advise clients on their needs as well act as the main Parexel client contact during the project. Contributes idea for approaches to new clients or new service offerings. • Provide technical leadership and training to more junior staff within the team, and ensure own skills are up to date; contribute to thought leadership initiatives. • Apply data analytics to support research projects and collaborations within the team. This will include supervising the conduct of statistical analyses, analytic datasets creation, and performing quality control. • Leading development study protocols, statistical analysis plans and coaching the team through the analytical work process, specifically determining data structures and statistical coding algorithms. • Follow comprehensive quality checking and validation processes. • Develop study protocols and define analytical variables collaboratively with external research scientists and biostatisticians.*Qualifications* • A minimum of 8 years' experience working with in real-world evidence, with particular emphasis on large relational databases, processing large administrative healthcare datasets (medical and pharmacy claims), and or clinical databases (Electronic Health Records), creating final analytical databases, conducting secondary data analyses, and developing research study designs. • Recent Pharmaceutical/CRO experience preferred. • Experience in Real World Evidence, epidemiology, or register studies. • Past experience in the development of real world evidence proposals is an advantage. • Demonstrated evidence of publications will be viewed favorably. • Minimum Master's degree (PhD preferred) in the area of outcomes research, epidemiology, biostatistics, statistics, health services research, or a related field.*Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* The purpose of the role is to support the development of health economic models, such as cost-effectiveness and budget impact models, to understand the economic value of clients' products and interventions. • Provide high quality, timely, scientific/strategic solutions to meet client needs • Conduct and analyse primary and secondary research, which will shape the development of strategic recommendations • Build and check health economic models, using appropriate software tools, to elucidate and express the economic value of clients' products • Systematically search for and synthesise disparate qualitative and quantitative health economic evidence, and interpret meaningfully • Write, refine, review and critique sections of reports, journal manuscripts and other deliverables for client or external delivery • Act as primary point of contact and Project Lead, providing guidance and instruction to junior team members while being supported by the Project Director (senior team member)*Qualifications* • Strong computing skills (MS Office) including MS Excel • High analytical ability • A high degree of written accuracy and attention to detail • Good communication skills, both oral and in writing, especially in the relaying of technical information • Self-motivation, enthusiasm, ambition and flexibility • Fluent English • Training and experience in health economics including the conceptualization and development of cost effectiveness and budget impact models (5+ years, ideally in a consultancy environment) • Experience of programming and software such as VBA, SAS, R is an advantage • Keen interest in medical research, provision of healthcare and the pharmaceutical industry*Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* *Parexel*is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability. *Due to a growing portfolio, we are looking for a Senior Initiation Clinical Research Associate (Senior Study Start Up Specialist) on a temporary contractor basis. This is a 1.0 FTE contract and itwill be on a 12 month basis.* As an Initiation Clinical Research Associate, you will act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the*start-up phase*.* Build relationships with investigators and site staff. * Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include: * Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. * Conduct remote Qualification Visits (QVs). * Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution. * Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. * Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. * Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. * Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. * Forecast, develop, manage, and revise plans and strategies for: * IRB/IEC and MoH / RA submission/approval, Site activation, * Patient recruitment & retention. * Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. * Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start. * Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required. * Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements. * Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns. * Assess & manage test article/study supply including supply, accountability and destruction/return status. *Qualifications* *ore about you* On your first day we'll expect you to have:* Science degree required.Medical or Pharmacy preferred. * Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word. * Sound problem solving skills. * Able to take initiative and work independently, and to proactively seek guidance when necessary. * Advance presentation skills. * Client focused approach to work. * Ability to interact professionally within a client organization. * Flexible attitude with respect to work assignments and new learning. * Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise. * Willingness to work in a matrix environment and to value the importance of teamwork. * Strong interpersonal, verbal, and written communication skills. * Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables. * Effective time management in order to meet study needs, team objectives, and department goals. * Developing ability to work across cultures. * Shows commitment to and performs consistently high quality work. * Ability to successfully work in a ('virtual') team environment. * Consulting Skills * Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned. *Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* Develop and implement strategic recruiting plans, manage vendors, utilize social networking and recruitment databases in order to deliver a selection of highly qualified candidates in a timely manner *Key Accountabilities*: * Provide hiring managers with competency-based selection recommendations * Manage candidates through the interview process, gather feedback * Collaborate with SBU assigned HRBPs throughout the selection process * Manage offers * Develop recruitment strategies that include direct sourcing, recruitment advertising, social networking, research, corporate alumni, and employee referral programs * Produce bi-weekly recruitment activity reports for hiring managers * Resolve all recruitment challenges through professional consultation and talent advisory skills *Qualifications* *Skills:* * Creative in problem solving and ability to operate constructively in a changing environment, while being flexible and adaptable with excellent organizational skills * Excellent written and verbal communication skills; ability to communicate effectively with employees and leaders at all levels of the organization (local legal language and English) * Demonstrates integrity in all business interactions and honors personal commitments * Ability to work with multiple stakeholders and tasks, prioritize workload with attention to detail * Strong IT skills including Word, Excel, Outlook, PowerPoint *Knowledge and Experience*: * Experience within a fast-paced, professional and progressive environment * Exposure in use of applicant tracking systems and job boards * Experience in recruitment for several European countries * Extensive selection experience using a variety of techniques, especially in telephone interviewing *Education:** Bachelor's degree *Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

We are now open for our Summer 2022 Placement opportunities for Biostatisticians to join us on a year long basis, as part of their placement year, based in our Sheffield office!Your time hereAs a Biostatistician at Parexel, you will have the opportunity to grow your career and be part of a dynamic and flexible working environment. You can learn from a multi-cultural team that uses their understanding of advanced statistical methods to apply complex and innovative statistical approaches for a broad spectrum of therapeutic areas. Junior staff can take advantage of our mentoring program, while further in your career you may have the opportunity to support key client partnerships and be involved in business development activities.Our Biostatisticians are not only focused on delivering quality results for our client's needs, but also value working with one another; the group is a close-knit team with a great collegial atmosphere. Our virtual resources support our teams to work collaboratively and effectively across the globe. The overall long tenure of our team integrates a depth of knowledge and experience. Working together, you will create paths to answers and contribute to new therapies which ultimately will impact the patient.What you'll doLeverage your expertise. Develop and evaluate statistical analysis like tables, figures and data listingsTake quality seriously. Participate in quality control of statistical deliverablesBroaden your experience. Be exposed to different therapeutic areas and statistical methodologiesDevelop your knowledge. Leverage ongoing training and development opportunities Qualifications More about youExperience in Statistics and its applications to clinical trials or observational studies, in industry or course workPrior experience with SAS or R programming desirableEducation:Be studying in your penultimate year of study in either biostatistics, statistics, mathematics , or another relevant discipline (preferred) and looking for a year long placement as part of your degree.Skills:A self-reliant, quality focused mindset, with the ability to learn quickly and work within a matrixed teamProficiency in written and spoken EnglishA strong work ethic to promote the development of life changing treatments for patientsA little about usParexel is proud to be a leading Clinical Research Organization, with colleagues committed to make a difference. As a member of our global team, you'll have discussions in an open environment-sharing expertise, promoting learning, and getting to know one another on a personal level. You'll also experience supportive management that encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level statistical role, or into line management, Parexel prides itself on career opportunities for our employees.

*Job Description* This is a Graduate level opportunity for a Statistical Programmer I to come and join the team in Sheffield. So if you are a recent Graduate or have some experience in Statistical Programming - apply now. • Check own work in an ongoing way to ensure first-time quality. • Use efficient programming techniques to produce low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. *Training *• Maintain and expand local and international regulatory knowledge within the clinical industry. • Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. *General *• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. *Qualifications* *Skills * • Excellent Analytical skills with Knowledge and understanding of the programming and reporting process. • Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. • Ability to learn new systems and function in an evolving technical environment. • Attention to detail. • Ability to successfully work as part of a global team. • Work effectively in a quality-focused environment. • Effective time management in order to meet daily metrics or team objectives. • Show commitment to and perform consistently high quality work *Education * BSc student studying a degree in statistics, mathematics, computer sciences, computer and management studies. *Language Skills * * Competent in written English. * Good communication skills.*Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* *Parexel has an existing opportunity for University Graduates, looking to take their first step towards a career in Clinical Research! An ideal candidate will be passionate about Clinical Research and ready to develop their professional career towards a Clinical Research Associate role in 6-12 months.* *This role will be initially office -based in Uxbridge with the flexibility of home working.* As the Clinical Operations Assistant (COA) you will maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality. Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate. You will also support all site management team members on local billable administrative tasks and assist with QC of Central files. This is an excellent entry level role into clinical operations and will allow for future development into either of our monitoring or study start up teams. *Key Accountabilities:* * Project Central Files & Clinical Trial Management Systems Maintenance and Updates. * Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan. * Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP). * Photocopy, print distribute and retrieval of documents, as needed. * Maintain basic quality check procedures to ensure accurate maintenance of documents. * Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only). * Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance. * Support to all local site management team members (CRA). * Organization of translations of study document (e.g. contacting translation company, requesting approval via Oracle, following up with translation company to ensure timely delivery). * Payment/invoice processing including internal follow up with payment specialists in Finance. * Courier shipment of study document to the sites, vender and clients. * Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within Parexel. *Qualifications* *An ideal candidate will possess:* * A degree in the life sciences. * Some initial clinical research or clinical operations experience in either pharma, CRO or academia is preferred. * Fluent English is a must. * Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word. * Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines. * Excellent oral and written communication skills. * *Please include your Cover Letter along with the CV in your application.* *Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* Under the Direction of Senior Director, Customer Strategy, drive the growth and innovation of Parexel Medical Communications. Responsible for developing and expanding new business opportunities in liaison with Commercial and Subject Matter Experts (SMEs) across Parexel. Lead the sales proposal and pitch process and work closely with Commercial and SMEs to ensure client satisfaction. Your ability to understand our clients' needs and provide specific and tailored solutions to achieve their objectives is critical to ensure our reputation as one of the best strategic partners and medical communications providers globally.*Qualifications* Knowledge and experience Minimum Work Experience •8+ years in life sciences, pharma, biotech, or consulting •5+ years in a medical communications role •1+ years in business development or planning/strategic new product role Education: • Degree or higher, ideally in Life Sciences and relevant work experience Skills • • Demonstrated pharmaceutical industry, medical communications and business development experience. . • Proven understanding of the pharmaceutical and biotech marketplace and evolving needs. • Proven experience in acquiring new clients and ability to secure new business awards. • Excellent stakeholder relationship management. Able to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client's business. *Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* *We are now open for our Summer 2022 Placement opportunities forBiostatisticians to join us on a year long basis, as part of their placement year, based in our Sheffield office!* *Your time here* As a Biostatistician at Parexel, you will have the opportunity to grow your career and be part of a dynamic and flexible working environment. You can learn from a multi-cultural team that uses their understanding of advanced statistical methods to apply complex and innovative statistical approaches for a broad spectrum of therapeutic areas. Junior staff can take advantage of our mentoring program, while further in your career you may have the opportunity to support key client partnerships and be involved in business development activities. Our Biostatisticians are not only focused on delivering quality results for our client's needs, but also value working with one another; the group is a close-knit team with a great collegial atmosphere. Our virtual resources support our teams to work collaboratively and effectively across the globe. The overall long tenure of our team integrates a depth of knowledge and experience. Working together, you will create paths to answers and contribute to new therapies which ultimately will impact the patient. *What you'll do* • Leverage your expertise. Develop and evaluate statistical analysis like tables, figures and data listings • Take quality seriously. Participate in quality control of statistical deliverables • Broaden your experience. Be exposed to different therapeutic areas and statistical methodologies • Develop your knowledge. Leverage ongoing training and development opportunities*Qualifications* *More about you* • Experience in Statistics and its applications to clinical trials or observational studies, in industry or course work • Prior experience with SAS or R programming desirable Education: • Be studying in your *penultimate year of study in either biostatistics, statistics, mathematics*, or another relevant discipline (preferred) and looking for a year long placement as part of your degree. Skills: • A self-reliant, quality focused mindset, with the ability to learn quickly and work within a matrixed team • Proficiency in written and spoken English • A strong work ethic to promote the development of life changing treatments for patients *A little about us* Parexel is proud to be a leading Clinical Research Organization, with colleagues committed to make a difference. As a member of our global team, you'll have discussions in an open environment-sharing expertise, promoting learning, and getting to know one another on a personal level. You'll also experience supportive management that encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level statistical role, or into line management, Parexel prides itself on career opportunities for our employees.*Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* Job Purpose: Oversee and manage Procurement of study and general supplies, stock control, invoice processing, logistics management including shipments in/out, reception cover and hospitality within the London, Early Phase Clinical Unit. A business critical role ensuring that: - * Procurement and Stock Control - ensure procurement process is followed and that orders, including consumables and equipment for studies, are placed on a timely basis, in alignment with sponsor protocol requirements and once received are stored in an appropriate manner depending on ordering department. Set up and maintenance of Stock Control system to prevent over-ordering of supplies resulting in tied up cash and wastage through expiry. * Provide Reception cover including all duties performed by the incumbent; Processing of GP Payments, Volunteer Payments and coordination of volunteers through Screening and Out-Patients. * All the logistics around visitors to the Unit are handled in a professional and timely manner. Liaise with Facilities and Cleaning staff within the Unit as required. Key Accountabilities: * Procurement and stock control * Responsibility for managing and monitoring procurement process with all relevant areas to ensure studies are not delayed due to late delivery and ensure best pricing is obtained for all purchases. * Set-up and maintenance of an inventory control system. * Responsible for managing clinical and general unit stock, supplies and returns. * Ensure proper support of all client logistics for visits to the London Unit - the Client Experience will encompass recommendation of hotels, provision of transportation, location maps as required, booking of meeting rooms and catering for the visits. * Ensure that the Facilities and Cleaning contractors are delivering a first class service which does enhances the presentation of the unit to all internal and external customers. * Ensure that all established timelines relating to areas of responsibility are met. * Taking minutes in meetings. * Any other duties assigned by the Unit Head and Management team. *Qualifications* Knowledge and Experience: * Prior stock control and procurement experience preferred. * Administrative experience in a professional office environment desirable. * Good written and spoken English. Education: * Min of GCSEs including English Language & Maths. * Further qualifications in IT, business administration and/or Administrative/Secretarial qualification is desirable. *Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* For assigned accounts, have global responsibility for the design, and accountability for the implementation and ongoing production support, of comprehensive solutions (process & technology) to meet the specific needs of the accounts. Leverage technology enablers to make the conduct of clinical research easier for patients, sites, project teams and sponsors. Through high quality and timely delivery, support the profitability of Clinical Development and aid new business acquisition. The Senior Director, Client Technology Partners (CTP) provides global strategic leadership for the most challenging accounts within the clinical trial technology space, taking on the most complex assignments in a consulting role. Overall accountability for multiple strategic accounts beginning from pre-sales, by helping to win the contract, through post-award, by delivering and supporting the solutions. This requires a consulting mindset incorporating a mix of detailed clinical trial/study business process knowledge, in addition to technology solutions, to identify and provide the best fit solutions. With a unique mix of knowledge and understanding, a critical part of the role is to identify innovation opportunities in the spirit of continuous improvement. The Senior Director also provides mentorship and expertise to all CTP. Due to their deep knowledge, they are subject matter experts within the department or company. To increase efficiency, profitability & quality, the Senior Director will steer the teams toward standard solutions where possible.*Qualifications* Skills: • Demonstrated consulting skills • Able to continually add to knowledgebase, and share acquired knowledge with colleagues in an efficient manner • Demonstrated ability to negotiate with senior executives and sell solutions that align with the goals of the role • Excellent communication, both written and verbal Knowledge and Experience: • Demonstrated deep understanding of: o Clinical trials/studies, and the variation in need from Phase I through Phase IV o Technology Solutions, and how they enable clinical trials / studies, including CTMS, EDC, IRT, eTMF DCT / platforms, eConsent, eCOA (both ePRO & ClinRo), wearables, telehealth, data warehousing, integration technologies. o Consulting toolsets o Business Case Analysis and Cost Benefits Analysis Education: • Degree in life science, computer science or other relevant experience required. • MSc / MBA / Advanced degree preferred.*Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

*Job Description* As a Data Monitoring Committee (DMC) Statistician, you will develop and review DMC statistical analysis plans and author/co-author DMC summary reports and DMC Charters. You will use your knowledge to advise, provide guidance and to oversee the quality control of statistical deliverables for DMCs. As the DMC Statistician within a study team, you will direct the activities for the independent [unblinded] team on a study and be accountable for the relevant deliverables. You will be the first person on a trial to be aware of the safety and efficacy results and be able to monitor them as they progress, providing interpretation of the statistical aspects to the DMC board. Senior, Principal, and Senior Principal level DMC Statisticians at Parexel are client-facing and play an integral part in the study team. Our Biostatistics DMC team is not only focused on delivering quality results for the needs of DMC board members as well as those of our clients, but also value working with one another in a flexible environment. Our virtual resources support our teams to work collaboratively and effectively across the globe. *What you'll do* Supervise, advise and review: * Leverage your expertise. Use novel analysis strategies and execute them using efficient programming techniques (software: SAS, R). Perform sample size, power and conditional power computations to establish efficacy/futility on a trial. * Be at the fore of new technologies. Using interactive data visualisation tools to facilitate a superior way to interrogate data. * Foster teamwork. Perform intricate statistical analyses and provide input to statistical reports. * Share knowledge. Provide input to DMC analysis plans and DMC summary reports. * Impact the process. Be a proactive advisor for all types of analysis from the proposal process through the project life cycle. * Take quality seriously. Review unblinded analysis data sets and quality control all relevant statistical analysis deliverables. * Coach and mentor. Train and uplift junior members of the team. Cooperate and network: * Build relationships. Liaise with other biostatistical and company departments to optimize global efficiency. * Work collaboratively. Coordinate Biostatistics related project activities for successful completion within given timelines and budget. * Interact with heart. Coordinate with DMC boards and clients with regards to data analysis, scope of work, and budget. * Demonstrate our expertise. Represent Parexel at client and DMC meetings. *Qualifications* *More about you* On your first day we'll expect you to have: Experience: * A minimum of 5 years industry (or directly relevant) experience * Experience of performing the role of independent [unblinded] statistician supporting a DMC * A thorough understanding of the statistical aspects of either clinical trials and/or observational studies * Experience in statistical analysis in a clinically related subject, either within clinical trials or in Epidemiology * SAS programming and/or R programming skills (desired) Education: * A Masters or Ph.D. level education in biostatistics, statistics, mathematics, or another relevant discipline Skills: * Confidence, be self-reliant and a quick learner who enjoys working in a matrixed team * The ability to fluently explain statistical concepts using layman's language * The ability to work to exacting timelines * Good leadership skills * Very strong oral and written English communication skills * The ability to travel as required * A strong work ethic to promote the development of life changing treatments for patients *Why Work at Parexel* *There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide? That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step. How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.