Clinical Trial Manager Uk In Vitro Diagnostics Job In Location Na

Clinical Trial Manager position, UK based - 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 permanent, full-time, UK-based Clinical Trial Manager with considerable Medical Devices experience.

Career Responsibilities

• Designs, plans and executes study management and clinical monitoring activities of large-scale trials in support of IVDR submissions for diagnostic devices.
• Prepare and author IVDR gap assessments and Clinical Performance Reports.
• 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.)
• Effectively lead the operational clinical team for assigned studies and delegate appropriate tasks, assignments, and responsibilities to subordinates.
• Develop and administer budgets, schedules and performance requirements for assigned studies.
• Oversee the successful and efficient execution of assigned studies from study start up to study close out.
• Participate in CRO/vendor selection process for outsourced activities as applicable.
• 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.
• Collaborate with the Legal Department to develop study contract templates across the trial and specifically for each study site.
• Provide feedback on study/protocol design as needed
• Develops the Site Monitoring Plan and ensures CRA compliance with the plan
• Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
• 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
• Works under minimal supervision and demonstrates a high degree of proficiency
• Additional project and tasks as determined by department and organizational needs
• Travel may be approximately 20-50%

Education & Experience

Minimum BA or BS and 10 years of related experience; 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

• Strong technical writing skills
• Deep understanding of IVDR and applications
• Advanced knowledge of clinical trial practices and regulations
• Advanced knowledge of clinical trial, design, clinical trial databases, and data analysis for IVD clinical trials
• 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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