ICON Clinical Research

Job Advert Posting ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. As a Senior Project Manager, Laboratory you will ensure client satisfaction by acting as the clients main contact from set up to day to management of studies. *The Role:* * Act as the sponsor's main contact person in all matters regarding our central laboratory services, following up to and responding to clinical study specific inquiries from a range of internal & external stakeholders. * Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate). * Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study Project Management Plan * Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure. * Provide Sponsors with study management reports as required and agreed. Provide client with support on ICOLabs and iSite systems. * Proactively monitor study budget through monitoring of Protocol Tracking reports and other tools provided to assist * Regularly use the PM Dashboard to help monitor study progress and communicate to Sponsors in a timely manner if issues identified may require further investigation * Set the timelines for and monitor the progress of shipment requests for storage samples and verify data. * Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Face to Face Governance meetings. * Serve as a leader, mentor and consultant to more junior team members in resolving issues or questions as they arise. * Serve as a gateway for escalation of PM issues to PM Manager and Senior/Executive Management *To be successful in the role, you will ideally have:* * In depth proven experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences related organization * Prior relevant experience successfully performing a Project Management role in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture. * Successful management in providing technical services for multiple clinical trials, including Presentation at Investigator Meetings, Implementation of protocol amendments, Completion of Laboratory Configurations, Trial reconciliations, Participation in sponsor/regulatory audits, Bid Defences * Bachelor's degree or local equivalent in Science, Business or related Field and/ or an alternative combination of experience, education, and training. *Benefits of Working in ICON:* Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. *ICON Patient Centred Outcomes *is currently seeking an *Research Associate* *(Qualitative)* to join our team! *Location: UK or France* *Home or Office based* ICON Patient Centred Outcomes (PCO) is part of ICON plc, a leading global Clinical Research Organization headquartered in Dublin, Ireland. Our PCO group undertakes consultancy projects for international clients in both the pharmaceutical and medical device sectors, supporting development of medicines and clinical trials. The work of the PCO group focuses on patient-centered research, including health related quality of life, disease signs and symptoms, treatment preference, adherence and satisfaction. The group is respected globally for the quality and innovation of their applied qualitative and quantitative work. Much of their work involves Clinical Outcome Assessment (COA) measurement development and evaluation including conducting patient interviews and focus groups and qualitative analysis. Our PCO team is primarily based in US (San Francisco, Boston, Gaithersburg, Raleigh), UK and France (Lyon), with ICON offices in most EU countries. We are looking for an individual who is looking to join a consultancy group where research experience is applied within a fast-moving commercial environment. In particular, we are looking for someone who is looking to apply their qualitative skills and join our growing team. You will have experience of applied research in an academic, health or commercial environment, and will have experience of, and interest in, qualitative research design and interpretation of results. *We have a strong preference for an individual with qualitative coding and analysis skills*. *Overview of the Role* * Assist with development of research materials (such as study protocols, interview guides) and conduct of literature reviews * Conduct interviews with patients, caregivers and clinical experts * Undertake qualitative data analysis using qualitative analysis software: eg MaxQDA, ATLAS.TI, NVIVO strongly preferred * Draft, review, and assist with client deliverables including reports, proposals and scientific manuscripts under the direction of senior team members *The ideal candidate will possess:* * Bachelor's (or higher) degree in a related field (such as sociology, anthropology, public health, epidemiology, psychology, or related discipline) or proven relevant experience * Experience in a related field in academic or industry environment * Understanding of scientific research methods and processes * Experience with qualitative methodology and analysis, knowledge of qualitative analysis software would be advantageous * Well-developed written and oral communication skills including fluent English written and spoken * Accuracy and attention to detail * The ability to work effectively as part of a team with a high degree of self-motivation *Benefits of Working in ICON:* Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. As a Clinical Research Associate at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results. The Role * Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation * Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested * Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required * Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness * Dependent on level of experience you may assist in training and mentoring less expert CRA's and/or lead CRA's working on international projects What you need * 18 months+ of monitoring experience in phase I-III trials as a CRA * Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data * You will possess excellent written and verbal communication in English * Ability to produce accurate work to tight deadlines within a pressurized environment * You will be asked to travel at least 2 days per week, and should possess a valid driving license *Benefits of Working in ICON*: Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture -one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career -both now, and into the future. ICON, including subsidiaries, 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. #LI-ICR2

* Project Manager - Real World Evidence Late Phase * *Location: *EU/UK wide (Home based)** ' At ICON, it's our people that set us apart' *Are you a Project Manager with experience in late phase studies, passionate about playing a key role within driving the overall management for regional and global clinical research projects?* ICON's Global RWE (Real World Evidence) late phase project management team is looking for an experienced Project Manager. *Role overview:* * As a Project Manager you will be expected to contribute towards a culture of business excellence with a focus on quality, scope, timelines adding value to the business and exceeding client expectations * You would be involved at the forefront of innovation and drive delivery using your project leadership expertise * Delivering successful working relationships with clients, cross functional project planning, scheduling and implementation, defining project scope, resource requirements and deliverables, risk mitigation strategies, associated action plan and issue resolution and budget management * Work in matrix teams on global international projects and be responsible for the overall coordination, implementation and completion of regional/global cross functional projects * Provide expert project management input into new business proposals and bid defense meetings *Role Requirements:* * Bachelor's Degree in medicine, science or equivalent degree * *Demonstrable Project Management experience within clinical research is essential* * *D**emonstrable experience within* *late phase studies in a CRO environment,** needed* * Experience in global/ multi country studies * Strong communication, planning, decision-making, negotiation, conflict management and time management skills * Willingness to travel up as needed

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. *The Role:* * Support Business Development in the winning of new business for ICON * Manage a team of Proposal Development Associates * Deliver high quality customer-focused proposals and budgets for the conduct of clinical trials in response to Requests for Proposals (RFPs) * Recognize, exemplify, and adhere to ICON's values which centre around our commitment to People, Clients, and Performance * Deliver high quality client-focused proposals, budgets and client grids for new business opportunities within given timeframe * Adhere to the proposal process * Evaluate and understand client requirements for incoming Request for Proposals (RFPs) and assign RFPs to appropriate Proposal Development Associates within specified timeframes * Manage and oversee the preparation, review and submission of proposals and budgets for new business opportunities within given timeframe * Manage and lead Proposal Development Associates throughout the proposal generation process including attending the proposal kick off, budget, strategy and other opportunity specific meetings as required * Oversee accurate preparation of budgets and specifications for contracts for new business awards within agreed timelines (where applicable) * Ensure that the appropriate personnel including Senior Management, Operations and Sales are involved as required in the preparation of budgets and specifications for new contracts (where applicable) * Consistently meet proposal submission timelines and adhere to Business Development SOPs and Working Procedures * Attend bid defence and other client meetings as a support role as required * Ensure Senior Management are apprised of the status of proposal preparation and elevate any issues or concerns * Recruit, train and mentor Proposal Development Associates as appropriate and as designated by the Global Director, Proposals. Develop a training plan for each Proposal Development Associate as required *Benefits of Working in ICON:* Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That's our vision. We're driven by it. And we need talented people who share it. If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry. ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. *Senior Project Manager- Medical Devices* *EU wide, flexible location* *The Role:* * Planning and implementation of cross-functional projects within medical device/IVD including cardiovascular device trials. * Facilitate the definition of project scope, goals and deliverables * Define project tasks and resource requirements. * Develop full-scale cross-functional project plans. * Assemble and coordinate project staff * Plan and schedule project timelines * Develop and Manage Risk Mitigation Strategies for projects * Track project deliverables using appropriate tools * Constantly monitor and report on progress of the project to all stakeholders * Implement and manage project changes and interventions to achieve project outputs * Project evaluations and assessment of results * Manage project study budgets and invoicing procedures according to study contract *To be successful in the role, you will have:* * At least 5+* years' experience in medical device* clinical research Industry required * At least 5 years' project management experience at a senior level * Experience of managing cardiovascular device trials preferred * Knowledge of ICH/GCP/FDA regulations and guidelines for medical devices and/or pharmaceutical/biologic agents * Bachelor's degree or equivalent in medicine, science or relevant discipline preferred. * Proficient in computer applications such as MS Word, Excel, Publisher, PowerPoint Benefits of Working in ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

*Contract Analyst II* *Location: Ireland, Dublin or UK (remote)* At ICON, it's our people that set us apart. As a global provider of drug development solutions, our work is serious business but that doesn't mean we can't have fun whilst we do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them? At ICON, we have an incredible opportunity for an expert Contract Analyst II to join the team. *The Role:* ICON's Client Contract Services team are responsible for the coordination, development and execution of all client contracts and change orders for newly awarded and on-going projects. As a *Contract Analyst II*, you will be responsible for developing and negotiating client contracts in collaboration with Finance, Legal and Operational teams at ICON. This is a busy and rewarding position, which plays a vital role at ICON. * Coordinate and develop contracts and change orders for newly awarded and on-going projects at ICON. * Work simultaneously on numerous contracts and/or change orders. * Lead discussion with ICON Legal, the Sales Team, and liaison with their respective Contracts Manager, as necessary, to determine the appropriate terms and conditions to be included in the contracts (inclusive of Start-up Agreements) and change orders. * Understand applicable ICON costing tools, client budget grids, and any tools and templates developed within the Client Contract Services group. Ability to explain the costing process to someone without a financial background. * Solicit input and review of contracts and change orders from the relevant operational departments. * Understand reasons and challenge supporting information provided by the project team related to budget changes (timeline, specifications, tasks, hours, etc.) and that the budget changes are reasonable and justified. * Develop cash neutral payment schedules as required. * Recognize when client questions/comments need required input and review by Legal and/or operations/senior management. * Provide project/financial analysis on the project budget to justify supporting information from the project team on prior to client submission. * Develop and maintain client/project files and tracking tools. * Manage and prioritize workload in relation to timelines and client submissions. * Build relationships with ICON project teams, sales, proposals, finance, and project analysis. * Build relationships with clients, other ICON service areas and vendors. * Provide the relevant information required for negotiations and discussions with clients regarding cost proposals/change orders/contracts to the Contract Manager, the respective Sales personnel, and project teams. * Organize, lead, chair, and manage internal meetings and/or client related meetings required related to contracts and change orders. *What you need* * Degree qualified * 3-5 years' experience within a similar role * We will also consider applicants who have a background in Proposals, Data Management or Financial Business Partnering. * The team uses excel as their costing tool, it is important that you have advanced excel skills * A great team player who is willing to support the team as required. * Brilliant communication skills with the ability to develop meaningful relationships with other teams at ICON and our clients. *Why join us?* Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. Ongoing development is vital to us, and as a *Contract Analyst II*, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success. *ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.* *EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin.* LI#-GBS1

*Senior Internal Auditor, Quality and Compliance * *Location:* Remote UK or Ireland At ICON, it's our people that set us apart. As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them? At ICON, we have an incredible opportunity for a we have an incredible opportunity for a *Senior QA Auditor *to join the team. This role can be based out of the UK or Dublin. If UK based there will be an expectation of travel to the Dublin office. *The Role* As a *Senior Auditor within Quality and Compliance* and reporting to a senior manager within the team, you will be responsible for performing tasks relevant to the assigned Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defence, case management and CAPA management. There is travel of up to 35% involved with this role. * To lead and support external audits and inspections of ICON including scheduling, preparation and hosting. * To Lead and support inspection readiness activities, including inspections of ICON and/or investigator sites. * To Lead and support CAPA management for external audits of ICON and regulatory inspections of ICON and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements, Good Clinical Practice guidelines and relevant regulations, including ensuring appropriate corrective and preventative actions are put in place and CAPAs are followed until resolution. * To Lead / Support Quality Issues (non-conformance / potential NC and complaints), including ensuring appropriate root cause analysis, implementation of corrective and preventative actions and follow-up and effectiveness of resulting CAPAs. * Lead / Support inspection readiness activities, including inspections of ICON and/or investigator sites. * Lead CAPA management for inspection of ICON and /or investigator sites, where needed, including ensuring any Inspection CAPA commitments are tracked and followed until resolution. * Lead CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up. * Lead / support quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented. * Ensure that CAPAs are formally recorded and reported and that corrective/preventive actions are documented and followed until resolution. * Identifying and tracking required effectiveness checks and ensure effectiveness checks are completed within the require timelines. * Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements. * Support other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary. *What you need* * Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials. * Knowledge/ experience in hosting external audits and/or regulatory inspections * Knowledge / experience in CAPA management, including performing effective root cause analysis * Ability to review and evaluate clinical data / records. * Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients. * Good problem resolution skills. * Good planning and organizational skills with the ability to multi-task and prioritize effectively. * Experience in Pharmaceutical and/or GXP environment including in-depth knowledge and experience in Quality Assurance auditing and/or with relevant regulatory compliance /Quality System , including quality system development and leading system development projects. * Ability to review and evaluate clinical data/records/systems/processes and make improvement recommendations. * Thorough knowledge of the clinical development process * Thorough knowledge and experience in performing and leading Root Cause Analysis. * Ability to manage complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed. * A super team player who is happy to support junior members of the team * Excellent communication and relationship building skills *Why join us?* Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. Ongoing development is vital to us, and as a *Senior Auditor, Quality and Compliance*, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success. #LI-GBS1