Clinical Project Manager- IVD

Lead the global study team with full accountability for study deliverables regarding quality, budget, and timelines. Develop key study documents including Design Validation Plans, protocols, training materials, and study reports. Oversee planning and operational aspects of companion diagnostics studies sponsored by Pharma partners, ensuring adherence to regulations, guidelines, and standard operating procedures for audit readiness. Execute sponsored studies through all phases from planning to close-out while tracking project performance to analyze short and long-term goals. Build and maintain strong relationships with cross-functional leaders, key internal and external stakeholders, and alliance partners including CROs. Collaborate across Clinical Operations to develop and implement best practices.