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Looking to build a career in clinical research and clinical trial documentation? JSS Medical Research is hiring a Clinical Trial Associate (eTMF) in Mumbai. This role is ideal for candidates with foundational knowledge of eTMF systems, clinical documentation, and ICH-GCP compliance.
If you have exposure to platforms like Veeva Vault or MasterControl and want to work closely with clinical operations teams, this opportunity offers strong career growth in the clinical trials and CRO industry.
๐งช Key Responsibilities
- Manage and maintain clinical trial documents within the electronic Trial Master File (eTMF) system
- Ensure document compliance with ICH-GCP and regulatory guidelines
- Perform quality control (QC) checks on TMF documents
- Track missing, incomplete, or outdated documents and follow up with stakeholders
- Support audits, inspections, and TMF reviews
- Maintain TMF structure, index, and completeness throughout the study lifecycle
- Prepare TMF metrics and status reports
- Coordinate with cross-functional teams like Clinical Operations, Regulatory, and Data Management
- Ensure adherence to SOPs and study-specific procedures
๐ Qualifications & Eligibility
Educational Requirements:
- B.Pharm, M.Pharm
- B.Sc / M.Sc (Life Sciences)
- BAMS, BHMS, BDS, Physiotherapy, or equivalent
Skills Required:
- Basic understanding of clinical trial processes and TMF reference model
- Experience or exposure to eTMF systems (Veeva Vault, MasterControl, etc.)
- Knowledge of ICH-GCP guidelines
- Strong attention to detail and documentation accuracy
- Ability to manage multiple tasks and meet timelines
๐ผ Preferred Candidate Profile
- 0โ1 year experience in clinical research or documentation roles
- Familiarity with clinical trial documentation workflows
- Good communication and coordination skills
- Audit readiness mindset and compliance awareness
๐ Benefits of This Role
- Entry into the clinical research industry (CRO domain)
- Hands-on experience with eTMF systems and regulatory documentation
- Exposure to global clinical trial processes
- Opportunity to work with cross-functional clinical teams
- Career progression into roles like Clinical Trial Coordinator, TMF Specialist, or CRA
๐ฉ How to Apply
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