Clinical Trial Manager

Clinical Trial Manager

ICON

Ireland

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.

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