Sun Pharmaceutical Industries Ltd has announced a new opportunity for the role of Clinical Trial Assistant in Mumbai under its Medical Affairs & Clinical Research division. Candidates with experience in clinical research, clinical trial coordination, TMF management, and GCP compliance are encouraged to apply.
This Clinical Trial Assistant job in Mumbai is ideal for B.Pharm, M.Pharm, Pharm.D, Nursing, Life Sciences, and Clinical Research professionals looking to build a career in clinical operations and clinical trial management.
Job Overview
| Details | Information |
|---|---|
| Job Role | Clinical Trial Assistant |
| Company | Sun Pharma Laboratories Ltd |
| Department | Medical Affairs & Clinical Research |
| Location | Mumbai, Maharashtra, India |
| Experience Required | 1โ2 Years |
| Qualification | Bachelorโs/Masterโs in Life Sciences, Pharmacy, Nursing, Clinical Research |
| Job Type | Full Time |
| Work Mode | Office Based |
Key Responsibilities of Clinical Trial Assistant
The selected candidate will support clinical research operations and ensure smooth execution of clinical studies.
Administrative & TMF Management
- Maintain and organize Trial Master File (TMF) and Investigator Site File (ISF)
- Ensure study documents comply with ICH-GCP and regulatory guidelines
- Update clinical study trackers and maintain documentation
Clinical Study Coordination
- Support study planning, initiation, conduct, and closeout activities
- Assist Clinical Research Associates (CRAs) with site coordination
- Track enrolment status, monitoring visits, and study milestones
- Manage invoice tracking and vendor payment coordination
Regulatory & Compliance Support
- Assist in ethics committee and regulatory submissions
- Ensure compliance with SOPs, NDCTR 2019, and ICMR Guidelines
- Track approvals, licenses, and essential regulatory documents
Data & Reporting
- Maintain study dashboards, logs, and monitoring trackers
- Perform quality checks on clinical trial documents
- Support audit and inspection readiness activities
Vendor & Site Coordination
- Coordinate with labs, couriers, and study vendors
- Support study sites with training documents and trial-related queries
Eligibility Criteria
Educational Qualification
Candidates must possess any of the following:
- B.Pharm
- M.Pharm
- Pharm.D
- BSc/MSc Life Sciences
- Nursing
- Degree in Biology, Pharmacology, Healthcare, or related discipline
- PG Diploma in Clinical Research
Experience Required
- 1โ2 years of experience in Clinical Research or Clinical Research Coordinator roles
- Knowledge of:
- ICH-GCP Guidelines
- New Drugs and Clinical Trial Rules (NDCTR) 2019
- ICMR Guidelines 2017
- Drugs & Cosmetics Act related to clinical trials
Preferred Skills
- Strong clinical research and clinical operations knowledge
- TMF and ISF documentation expertise
- Attention to detail and analytical mindset
- Good communication and coordination skills
- Ability to work in matrix and cross-functional environments
Why Join Sun Pharma Careers?
Sun Pharmaceutical Industries Ltd offers a growth-oriented environment focused on continuous learning and career advancement. Employees gain exposure to:
- Clinical trial operations
- Regulatory documentation
- Vendor and site management
- GCP-compliant clinical research processes
- Cross-functional pharmaceutical industry experience
How to Apply
