- Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
- Assess protocol feasibility and support study planning, including resource allocation, budget considerations, and recruitment strategy development.
- Drive study start-up timelines, coordinating with internal teams (Regulatory, Contracts, Budget) to ensure efficient site activation.
- Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
- Develop and manage project plans, tracking milestones, timelines, enrollment targets, and overall study performance.
- Monitor site metrics including enrollment, data entry, and query resolution, implementing strategies to optimize study performance.
- Coordinate monitoring visits, audits, and investigator meetings, ensuring site readiness and proper study execution.
- Support regulatory and compliance activities, including essential document collection, IRB submissions, protocol amendments, and safety reporting.
- Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
Project Management