The pharmaceutical and clinical research industry in India is witnessing rapid growth, creating strong demand for professionals skilled in clinical documentation and data integrity. A leading global organization, IQVIA, is currently hiring for the role of Senior TMF (Trial Master File) Analyst.
This opportunity is ideal for experienced professionals ready to step into a leadership-focused role within a hybrid work model across India’s top life sciences hubs.
📂 What is a Trial Master File (TMF)?
In clinical research, the Trial Master File (TMF) is the backbone of a study. It contains all essential documents that demonstrate compliance with ICH-GCP guidelines and regulatory standards.
A Senior TMF Analyst ensures that every document is:
- Accurate
- Complete
- Audit-ready
- Easily retrievable
Think of TMF as the official story of a clinical trial—and you are its guardian.
🛠️ Key Responsibilities
1. Strategic Document Management
Manage the full lifecycle of clinical records—from document collection and digitization to archival and disposition—ensuring seamless workflows and timely delivery.
2. Compliance & Quality Control
Ensure all documents adhere to SOPs (Standard Operating Procedures) and study-specific filing structures. Maintain strict quality benchmarks.
3. Leadership & Team Development
Act as a mentor or team lead by:
- Training junior team members
- Supporting resource planning
- Driving process improvements
4. Audit & Inspection Readiness 🔍
Serve as the point of contact during audits. Ensure TMF and Site Master File (SMF) are fully compliant and inspection-ready at all times.
🎓 Required Qualifications & Skills
- Education: Bachelor’s degree in Life Sciences, Records Management, or related field
- Experience: Minimum 4 years in Records Management / TMF / Clinical Documentation
- Regulatory Expertise: Strong understanding of ICH-GCP and global compliance standards
- Technical Skills: Hands-on experience with eTMF systems and document imaging tools
- Soft Skills:
- Strong communication (global team interaction)
- Attention to detail
- Ability to manage multiple priorities under pressure
🌟 Why This Role Stands Out
- 🏠 Hybrid Work Model: Flexibility across Pune, Thane, and Bangalore
- 📈 Career Growth: Pathways into Clinical Operations, QA, or Leadership roles
- 🌍 Global Impact: Contribute to clinical trials that shape future healthcare
📝 How to Strengthen Your Application
To stand out, make sure your resume highlights:
- SOP compliance experience
- TMF/eTMF handling expertise
- Audit readiness and inspection support
- Team mentoring or leadership exposure
- Ability to manage timelines and quality metrics
