- Select and assess clinical investigators/sites based on study requirements.
- Negotiate study budgets, site contracts, and sponsor agreements.
- Conduct investigator meetings and support site initiation.
- Develop enrollment strategies and monitor recruitment/retention.
- Oversee study progress to ensure compliance with protocol, regulations, and Good Clinical Practice (GCP).
- Perform site monitoring visits and oversee APM/CRA performance.
- Identify and resolve study-specific issues and coordinate with vendors.
- Ensure timely study completion within approved budgets and resources.
- Track study progress, enrollment, and site performance.
- Manage study close-out activities, including data reconciliation and return of study supplies.
- Prepare sites for audits and inspections.
- Ensure compliance with Clinical Trial Material requirements, where applicable.
- Serve as the primary sponsor contact and provide regular study updates.
Desired Candidate Profile
- 7-10 years of experience in Clinical Trials & Clinical Research industry. MUST HAVE 2+ YEARS EXPERIENCE AS PROJECT MANAGER