- Clinical Operation
Posted:
7 August 2026 (29 days ago)
Application Deadline:
4 November 2026
Vacancies:
1 Vacancy
Job Summary
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
- / Pharm.D / (Life Sciences) / 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.