Document Management Associate (TMF)
Novotech, a leading global CRO, is hiring a Document Management Associate (DMA) in Bangalore. This opportunity is ideal for professionals with experience in Clinical Research, Trial Master File (TMF), eTMF systems, Clinical Documentation, and Regulatory Compliance.
The role focuses on maintaining inspection-ready Trial Master Files, supporting audits, managing clinical study documentation, and ensuring compliance with ICH-GCP guidelines and sponsor requirements.
Candidates interested in TMF jobs, eTMF specialist roles, clinical documentation careers, CTA jobs, and clinical operations opportunities should explore this opening.
📋 Job Overview
| Particulars | Details |
|---|---|
| Company | Novotech |
| Position | Document Management Associate (DMA) |
| Location | Bangalore, Karnataka |
| Department | Clinical Operations / TMF |
| Experience | Minimum 12 Months |
| Industry | Clinical Research / CRO |
| Employment Type | Full-Time |
| Application Mode | Online Application |
💼 Key Responsibilities
- Set Up and Maintain TMF/eTMF Systems.
- Review Clinical Study Documents for Quality.
- Upload and File Documents in eTMF Platforms.
- Generate TMF Quality and Progress Reports.
- Maintain Inspection-Ready Trial Master Files.
- Support Regulatory Inspections and Audits.
- Prepare TMF Documentation for Study Closeout.
- Maintain Department Trackers and Reports.
- Perform Quality Control Activities.
- Support Clinical Operations Process Improvements.
🎓 Eligibility Criteria
Educational Qualification
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
Experience Required
- Minimum 12 Months Experience
- CRO Experience Preferred
- Pharmaceutical Industry Experience Accepted
- Healthcare Industry Experience Accepted
🧠 Required Skills
- TMF & eTMF Management
- ICH-GCP Knowledge
- Clinical Documentation
- SharePoint Management
- Quality Control Activities
- Audit Readiness
- Document Review Skills
- Regulatory Compliance
- Reporting & Tracking
- Microsoft Office
- Attention to Detail
- Clinical Operations Knowledge
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