Novotech, a leading global Contract Research Organization (CRO), is hiring a Document Management Associate (DMA) in Bangalore, India. 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 (eTMF) and paper Trial Master Files for assigned projects.
- Ensure all study documents are scanned, uploaded, and filed correctly in SharePoint, eTMF, and paper TMFs.
- Review documents for quality and completeness, ensuring compliance with Novotech/client SOPs.
- Generate reports on document quality and provide updates to study teams for timely submissions.
- Keep the TMF “inspection-ready” at all times, ensuring contemporaneous filing.
- Support audits, regulatory inspections, and study closeout activities.
- Run monthly reports to verify file accuracy and resolve quality control findings.
- Assist in special projects, including archived study maintenance and process improvements.
Minimum Qualifications & Experience:
- 1 Year experience in a CRO, pharmaceutical, or healthcare industry.
- Hands-on experience with TMF (paper/eTMF) management in clinical research.
- Knowledge of ICH-GCP, regulatory requirements, and document control best practices.
- Strong organizational and quality control skills.
Why Join Novotech?
Novotech is a top-rated CRO with a presence in 34 offices worldwide, offering:
✅ Flexible work options & paid parental leave
✅ Inclusive workplace (LGBTIQ+, disability-friendly, caregiver support)
✅ Career growth in clinical research & biotechnology
✅ ISO 27001 & 9001 certified – ensuring highest IT security & quality standards
About Novotech
Novotech is a full-service CRO specializing in clinical trials across all phases. With 3,000+ employees and 5,000+ site partnerships, Novotech accelerates drug development with expertise in:
✔ Regulatory & ethics submissions
✔ Data management & biostatistics
✔ Medical monitoring & safety solutions
✔ Central lab services & ICH-compliant reporting
