Document Management Associate at Novotech
About Company
The Document Management Associate (DMA) at Novotech supports Trial Master File (TMF) activities, managing electronic and paper TMFs per project requirements, ICH GCP guidelines, and regulatory SOPs.
Minimum Qualifications & Experience
| Position Name | Organization | Qualification | Experience | Salary | Location |
|---|---|---|---|---|---|
| Document Management Associate | Novotech | B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences | 1-2 Years | ₹25,000 – ₹35,000/month | India |
Responsibilities
- Receive, set up, track, and maintain TMFs (electronic or paper) according to ICH GCP and SOPs.
- Utilize study systems like SharePoint for appropriate filing of study documents.
- Review document quality to meet essential requirements.
- Provide reports on document quality and update study teams.
- Maintain ‘inspection ready’ TMFs and ensure timely document filing.
- Adhere to TMF SOPs, KPIs, and process guidelines.
- Perform interim eTMF exports/uploads as needed.
- Run monthly file reviews to ensure accuracy.
- Prepare TMF for study closeout.