Clinical Project Manager- IVD

Job description

Job Summary The Project Lead is responsible for ensuring that all studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner within the planned timeframe and cost; ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements. Responsible for the timeline and budget planning and execution of studies. Assigns and ensures delivery of specific tasks to/from other members of the study team. Provides oversight to outside support including CROs, consultants and/or medical advisors. Responsibilities: Leading the global study team with full accountability for study deliverables regarding quality, budget, and timelines. Developing key study documents (e.g., Design Validation Plan, protocol, study training materials, study forms and templates, study report). Overseeing planning and operational aspects of companion diagnostics studies sponsored by Pharma partners. Ensuring adherence to regulations, guidelines, and standard operating procedures, and ensuring audit/inspection readiness. Executing sponsored studies for assigned areas of focus through all study phases (planning, start-up, c...