✅ Trial Master File (TMF) – Document Management Associate – Apply Now | Novotech CRO
📍 Location: Bangalore, India
🎓 Eligibility: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences
🧪 Experience: 1 Year+ (TMF/eTMF preferred)
📝 Job Type: Full-Time | Clinical Research | Documentation
🔎 Verified: ✅ Verified Job via Medical Jobs India – hitechplus.in
🧬 About Novotech
Novotech is a global full-service CRO based in Sydney, Australia with a presence in over 34 countries. Specializing in clinical trials across all phases, Novotech has 3,000+ professionals supporting biotech innovation globally. The company is ISO 27001 and 9001 certified, ensuring excellence in data and quality standards.
📄 Job Description: Document Management Associate (DMA)
- 📁 Maintain Trial Master File (TMF) in compliance with ICH-GCP & regulatory SOPs
- 🔍 Perform quality control, scanning, uploading & indexing in eTMF/SharePoint
- 📊 Track TMF completeness and ensure inspection readiness
- 📁 Prepare TMF closeout packages for audits and site closures
- 🤝 Work cross-functionally with CRA, sponsors, and vendors
✅ Eligibility & Skills
- ✔ Bachelor’s in Life Sciences, Pharmacy, or equivalent field
- ✔ 12+ months of experience in CRO/pharma/clinical research
- ✔ Hands-on experience in TMF/eTMF/SharePoint is preferred
- ✔ Familiarity with GCP, ICH, clinical trial documents, audit prep
🎁 Benefits at Novotech
- 🌐 Global exposure in a full-service CRO
- 🧘 Wellness programs & paid parental leave
- 📈 Career development in clinical operations
- 🤝 Inclusive workplace for LGBTIQ+, caregivers & disabilities
📌 Note Before You Apply:
Ensure your resume highlights document handling, TMF experience, and SOP compliance for better shortlisting chances.
👇 Application Link Will Be Visible in 15 Seconds 👇
🟢 Verified Job via Medical Jobs India – hitechplus.in
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