Project Manager(Clinical Trials)

Essential Functions:

• 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
  
• M.Pharma (Any Specialization), MS/M.Sc(Science) degree required.
  
• Strong understanding of GCP regulations and ICH guidelines.
  
• Excellent communication skills for effective client interaction.
• Should be from Mumbai.