Looking to build a career in Trial Master File (TMF) and clinical document management? A leading clinical research organization is hiring for the position of TMF Classifier II in Bangalore (Hybrid mode). This role is ideal for candidates with 1–2 years of experience in clinical research, eTMF, and GCP compliance.
If you have hands-on experience in eTMF systems, document classification, and audit readiness, this is a high-growth opportunity in the clinical operations domain.
📌 Job Details
- Role: TMF Classifier II
- Location: Bangalore (Hybrid)
- Job Type: Full-time
- Experience: 1–2 Years
- Qualification: Bachelor’s Degree (Life Sciences / Business)
- Application Deadline: March 25, 2026
🔍 Key Responsibilities
📂 eTMF Management & Classification
- Manage electronic Trial Master Files (eTMF) including Trial, Country, and Site artifacts
- Perform document classification under Smart Inbox and ARC review
- Handle document deletion and lifecycle management
✅ Audit Readiness & Quality Control
- Conduct visual quality checks (clarity, readability of documents)
- Perform Audit Ready Checks ensuring document accuracy and completeness
- Maintain TMF in a state of continuous audit readiness
📊 Compliance & Documentation
- Ensure compliance with:
- ICH-GCP guidelines
- Sponsor SOPs & company SOPs
- Track and manage essential clinical trial documents
🔧 Issue Resolution & Collaboration
- Identify and resolve TMF operational issues
- Collaborate with:
- Study teams
- Clinical operations
- Sponsors
📑 Audit & Inspection Support
- Prepare TMF for:
- Implement CAPA (Corrective and Preventive Actions)
📈 Continuous Improvement
- Participate in process improvement initiatives
- Support training and mentoring activities
🎓 Qualifications
Minimum Requirements:
- Bachelor’s Degree in Life Sciences / Business
- 1–2 years of experience in:
- Clinical research
- eTMF / document management
Required Skills:
- Strong understanding of:
- ICH-GCP guidelines
- Clinical regulatory documents
- Experience with:
- eTMF systems
- Microsoft Office & Adobe Acrobat
- Good communication and interpersonal skills
Preferred:
- Master’s Degree (Life Sciences / Business)
- Experience with clinical electronic systems (Veeva Vault, etc.)
💰 Salary (Estimated)
- ₹4.5 LPA – ₹7 LPA (based on experience and organization standards)
🚀 Benefits
- Hybrid work flexibility
- Exposure to global clinical trials
- Hands-on experience in eTMF and regulatory compliance
- Career growth in clinical operations / TMF / regulatory domain
- Opportunity to work with global sponsors
📥 How to Apply
