Location: Bangalore, India
Job Type: Full-time
Posting Date: April 8, 2025
Application Deadline: April 10, 2025
Job Description
Novotech, a leading global Contract Research Organization (CRO), is hiring a Document Management Associate (DMA) in Bangalore. This role is critical in managing Trial Master Files (TMF) for clinical trials, ensuring compliance with ICH GCP guidelines, regulatory requirements, and company SOPs.
Key Responsibilities:
- Set up, track, and maintain electronic and paper Trial Master Files (TMF/eTMF) for clinical studies.
- Review and ensure quality of study documents, adhering to Novotech/client SOPs.
- Upload, scan, and file documents in SharePoint, eTMF systems, and other study platforms.
- Generate reports on document quality and collection progress for study teams.
- Ensure TMF remains “inspection-ready” at all times with timely document filing.
- Support audits and regulatory inspections, resolving quality findings.
- Prepare TMF for study closeout, including exports/uploads for sponsors.
- Maintain department reports, checklists, and quality control schedules.
- Assist in Clinical Operations tasks, contributing to process improvements.
Qualifications & Experience:
- Minimum 12 months of experience in a CRO, pharmaceutical, or healthcare industry.
- Hands-on experience with TMF/eTMF management (paper & electronic).
- Knowledge of ICH GCP, regulatory requirements, and clinical documentation.
- Proficiency in SharePoint, eTMF systems, and document management tools.
- Strong organizational, quality control, and reporting skills.
Why Join Novotech?
Novotech is a top-tier CRO with a presence in North America, Europe, and Asia-Pacific. We offer:
✅ Flexible work options & paid parental leave
✅ Inclusive workplace (LGBTIQ+, disability-friendly, caregiver support)
✅ Wellness programs & career development opportunities
✅ ISO 27001 & 9001 certified, ensuring high-quality standards
About Novotech
Novotech is a full-service CRO specializing in clinical trials across all phases and therapeutic areas. With 3,000+ employees and 5,000+ site partnerships, we provide:
✔ Regulatory & ethics submissions
✔ Data management & biostatistics
✔ Medical monitoring & safety solutions
✔ Central lab services & ICH-compliant reporting
Our collaborative culture fosters innovation, making Novotech a great place to grow your career in clinical research.
How to Apply
📅 Last Date to Apply: April 10, 2025
📍 Location: Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore
