Clinical Project Manager- IVD and Cdx

IQVIA • Durham, NC

2d

About The Position

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.

Requirements

• Experience with Companion Diagnostic (CDx) studies.
• Team-oriented with excellent collaboration skills with a cross-functional team.
• Open-minded to learn new ways of doing things while leveraging previous experience.
• Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process
• Minimum of a bachelor’s degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field, at least 5years of prior relevant experience including > 1 year’s project management experience.
• Conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas.

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, conduct, and close-out).
• Overseeing projects to ensure completion on-time, within scope, and budget; tracking project performance to analyze the completion of short and long-term goals.
• Building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners, including CROs.
• Collaborating across Clinical Operations and other functions to develop and implementing best practices across Clinical Operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees