Clinical Project Manager- IVD
IQVIA · Durham, NC
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Role summary
This role leads in vitro diagnostic and companion diagnostic studies from conception through closeout, managing timelines, budgets, and cross-functional teams. The position requires overseeing regulatory compliance, key study documentation, and external partners while ensuring delivery of quality results. Candidates need at least five years of relevant healthcare experience, including one year in project management, plus knowledge of EU in vitro device regulations and product development.
What they're looking for
- Experience with Companion Diagnostic (CDx) studies
- Bachelor's degree in Life Science or related healthcare field
- Minimum 5 years relevant experience with >1 year project management
- Knowledge of EU In Vitro Device Regulation (IVDR) submission process
- Conceptual and practical knowledge of Product Development
- Strong cross-functional collaboration and team skills
- Basic knowledge of Clinical Operations or related areas
What you'll be doing
- Lead global study teams with accountability for quality, budget, and timeline deliverables
- Develop key study documents including protocols, design plans, and study reports
- Oversee companion diagnostics studies sponsored by pharmaceutical partners
- Ensure regulatory compliance and audit/inspection readiness across all study phases
- Track project performance and manage completion of short and long-term goals
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.