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Clinical Study Lead
hace 2 meses
We are seeking a highly skilled Clinical Study Lead to join our team at QIAGEN Gruppe. As a key member of our project core team, you will play a crucial role in the efficient launch of new or improved products in the Oncology and Biopharma Companion Diagnostics product areas.
Key Responsibilities- Study Design and Strategy: Develop and implement study designs, strategies, and plans for QIAGEN sponsored clinical studies, ensuring timely and budget-friendly execution.
- Stakeholder Coordination: Collaborate with internal and external stakeholders, including pharma partners and test labs, to coordinate clinical activities and provide regular status reports.
- Study Documentation: Develop and execute all study-associated documentation, including protocols, investigator brochures, informed consent documents, contracts, and reports, in compliance with relevant regulations, guidelines, and SOPs.
- Study Management: Manage and track clinical studies, ensuring timely completion within budget, escalating potential issues, and setting up and coordinating internal and external communications and meetings for correction, troubleshooting, and prevention planning.
- Site Management: Identify, enlist, and choose sites, and coordinate site management activities, ensuring study site preparation, equipment, and training are compliant with the clinical protocol and organization's SOPs.
- Team Coordination: Coordinate, supervise, and train internal and external teams as required, arrange and oversee site visits, and account for managing site auditing or QC visits where necessary to address or improve quality.
- Regulatory Oversight: Oversee regulatory requirements for conducting clinical performance studies in the appropriate geographies, liaise with internal and external stakeholders for regulatory deliverables, and ensure compliance with regulations such as IVDR and FDA requirements.
- Study Close-Out: Account for study close-out procedures on study binders, datasets, and study supplies, working with CTAs, CRAs, and Data/Statistics stakeholders for close-out documents and reviews.
- Reporting and Submission: Author clinical study reports and study-related submission documents to regulatory authorities, IRBs, and local agencies in line with their requirements and respond to queries.
- Education: Master's degree in Life Sciences, Molecular Biology, Biomedical Engineering, or similar; PhD or equivalent experience highly desirable.
- Experience: Significant employment experience within an in vitro diagnostic devices company, ideally in a Clinical Affairs/Operations related role; other devices or pharmaceutical experience will be considered. Experience within oncology and/or molecular companion diagnostics highly desirable.
- Regulatory Knowledge: Working knowledge of regulatory requirements and industry working practices, such as FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, and design control.
- Technical Skills: Understanding of electronic Data Capture (eDC), eTMF, and Clinical Trial Management System (CTMS) or similar clinical operations systems.
- Document Authoring: Experience of authoring clinical study documents, such as protocols, investigator brochures, informed consent documents, highly desirable.
- Travel: Willingness and availability to travel nationally and internationally as required, up to 20%.
