Clinical Trial Manager UK, In Vitro Diagnostics

Pharmaceutical Research Associates, Inc; Reading; On-site; GBP 40,000 - 80,000

Job description

Overview

Clinical Trial Manager position, Maidenhead (Eng), Galway (Ireland) or Jena (Germany) - In Vitro Diagnostics/Medical Devices

You will be partnering with a well-known leader in in vitro diagnostics, who offer a broad range of innovative ways for hospitals, labs, blood banks and clinics to diagnose and monitor health conditions with greater accuracy, speed, convenience and cost-efficiency. The result is smarter decisions for physicians and better health outcomes for patients.

Here in the ICON Strategic Solutions team, we are in an established partnership to supply a FTC (until end 2025), full-time, UK-based Clinical Trial Manager with considerable Medical Devices experience.

Responsibilities

Career Responsibilities

1. Designs, plans and executes study management and clinical monitoring activities of large-scale trials in support of IVDR submissions for diagnostic devices.
2. Prepare and author IVDR gap assessments and Clinical Performance Reports.
3. Provide comprehensive support of all operational aspects of clinical trials for which he/she is responsible for, including the review and approval of protocols and study-related documents (e.g., Regulatory Binder, Work Instructions, CRF Completion Guidelines, etc.)
4. Effectively lead the operational clinical team for assigned studies and delegate appropriate tasks, assignments, and responsibilities to subordinates.
5. Develop and administer budgets, schedules and performance requirements for assigned studies.
6. Oversee the successful and efficient execution of assigned studies from study start up to study close out.
7. Participate in CRO/vendor selection process for outsourced activities as applicable.
8. Manage Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management) as applicable.
9. Collaborate with the Legal Department to develop study contract templates across the trial and specifically for each study site.
10. Provide feedback on study/protocol design as needed
11. Develops the Site Monitoring Plan and ensures CRA compliance with the plan
12. Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
13. Participates in site start-up activities including site selection and regulatory document collection, review, approval and tracking; development of informed consent forms /assent forms as applicable
14. Works under minimal supervision and demonstrates a high degree of proficiency
15. Additional project and tasks as determined by department and organizational needs
16. Travel may be approximately 20-50%

The Clinical Project Manager (IVDR) will support the ongoing IVDR remediation program, to ensure IVDR compliance in a timely manner. The Clinical Project Manager will support data generation through literature searches and data collation and dissemination. This will be in support of on-market products going through IVDR remediation. It is expected that the Clinical Project Manager will generate the initial clinical performance report, which then will be updated on an annual basis and will provide support for IVDR study execution, as needed. The activities of this role will be in support of on-market products going through IVDR remediation as well as for new product requiring studies to comply with IVDR requirements.

The Clinical Project Manager will be skilled in medical writing, developing literature search protocols, and interpreting and selecting relevant scientific literature. Proficiency in Microsoft Word, including creating, tracking changes, and formatting documents to a final signable state, is essential. Furthermore, Clinical Project Manager will also be skilled in clinical study start-up and execution.

Qualifications

Education & Experience

Minimum BA or BS and solid related experience (ideally over 5 years experience would be preferred); Master's degree or Medical Technology Certification, familiarity with IVDR, experience with managing external CROs and on-site monitoring experience of IVD clinical studies is preferred.

Technical skills/Knowledge/Abilities

1. Strong technical writing skills
2. Deep understanding of IVDR and applications
3. Advanced knowledge of clinical trial practices and regulations
4. Advanced knowledge of clinical trial, design, clinical trial databases, and data analysis for IVD clinical trials
5. Proficient computer skills including Microsoft Office Suite

Why 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.

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.

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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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