Key Responsibilities

Plan, coordinate, and oversee clinical trials in compliance with ICH-GCP, CDSCO, and applicable regulatory guidelines.
Manage study timelines, site selection, site initiation, monitoring, and close-out activities.
Coordinate with investigators, CROs, ethics committees, vendors, and cross-functional teams for smooth study execution.
Track patient recruitment, study progress, protocol compliance, and data quality.
Review monitoring reports and ensure timely resolution of study issues and deviations.
Ensure Trial Master File (TMF) documentation is complete, accurate, and inspection-ready.
Support study budgets, vendor management, and project timelines.
Ensure compliance with SOPs, regulatory requirements, and quality standards.




Prepare study status reports and provide regular updates to management.
Support internal and external audits, regulatory inspections, and clinical quality initiatives.

Qualification

M.Pharm / Pharm.D / M.Sc (Life Sciences) / B.Pharm or equivalent.
Certification in Clinical Research will be an added advantage.

Experience

Sr. Executive: 3-6 years of experience in Clinical Operations.
Manager: 7–12 years of experience managing clinical studies in the pharmaceutical, CRO, or biotechnology industry.

📌 Sr.Executive/DM/Manager- Clinical Operation (Hyderabad)
🏢 Talental Consultings
📍 Hyderabad