Looking for Senior Document Management Associate jobs in India? Novotech, a leading global Contract Research Organization (CRO), is hiring experienced professionals for the Senior Document Management Associate (SDMA) role in Bengaluru, India. This opportunity is ideal for candidates with experience in Trial Master File (TMF), electronic Trial Master File (eTMF), clinical documentation, quality control (QC), and clinical operations.
Professionals with experience managing clinical trial documentation, ensuring inspection-ready TMFs, and supporting global clinical studies can apply for this exciting opportunity with one of the world’s fastest-growing CROs.
Job Overview
| Particular | Details |
|---|---|
| Company | Novotech |
| Job Title | Senior Document Management Associate |
| Job ID | 4025 |
| Location | Bengaluru, Karnataka, India |
| Department | Clinical Operations |
| Job Type | Full Time |
| Experience | 2+ Years |
| Industry | Clinical Research, CRO |
| Salary (Estimated) | โน7 LPA โ โน12 LPA |
Key Responsibilities
As a Senior Document Management Associate, you will:
- Manage paper and electronic Trial Master Files (TMF/eTMF).
- Upload, organize and maintain study documents throughout the clinical trial lifecycle.
- Ensure documents comply with ICH-GCP, regulatory guidelines and company SOPs.
- Perform comprehensive TMF Quality Control (QC) reviews.
- Review documentation for completeness, quality and regulatory compliance.
- Prepare quarterly QC checklists and monitor resolution of findings.
- Support TMF audits and regulatory inspections.
- Generate study documentation reports and monthly TMF metrics.
- Prepare inspection-ready TMFs during study conduct.
- Coordinate document collection with cross-functional clinical teams.
- Perform sponsor or third-party eTMF exports when required.
- Resolve audit observations and quality findings.
- Prepare TMFs for study closeout and archival.
- Mentor and train new Document Management Associates.
- Create quality control schedules and department checklists.
- Participate in SOP improvements and Clinical Operations initiatives.
Required Qualifications
Candidates should have:
- Minimum 2+ years of experience in a Clinical Research Organization (CRO) or similar environment.
- Practical experience handling Trial Master File (TMF) and electronic Trial Master File (eTMF).
- Experience with clinical document management systems.
- Knowledge of ICH-GCP, regulatory documentation and clinical trial processes.
- Strong documentation review and quality control skills.
- Excellent organizational and communication abilities.
- Experience in pharmaceutical, biotechnology or healthcare industries is preferred.
Preferred Skills
- Trial Master File (TMF)
- Electronic TMF (eTMF)
- Clinical Documentation
- Quality Control (QC)
- Inspection Readiness
- Clinical Operations
- SharePoint
- Document Upload
- SOP Compliance
- Regulatory Documentation
- Audit Support
- Clinical Trial Documentation
- Team Mentoring
Why Join Novotech?
Novotech offers employees:
- Flexible working environment
- Global clinical research exposure
- Career growth opportunities
- Continuous learning and development
- Wellness initiatives
- Inclusive workplace culture
- Paid parental leave
- Supportive leadership
- Opportunity to work on international clinical trials
Who Can Apply?
This opportunity is suitable for professionals with experience as:
- Trial Master File Associate
- TMF Specialist
- eTMF Specialist
- Clinical Document Management Associate
- Clinical Operations Associate
- Clinical Trial Documentation Specialist
- TMF Quality Control Associate
- Clinical Research Associate with TMF experience
How to Apply
