If you’re aiming to grow in Trial Master File (TMF) and clinical records management, this Senior TMF Analyst job at IQVIA India is a strong mid-level opportunity. With locations in Thane, Pune, and Bangalore, this role targets professionals with 4+ years of TMF, records management, or clinical documentation experience under ICH-GCP guidelines.
IQVIA, a global leader in clinical research services and healthcare intelligence, offers a structured environment for professionals looking to advance into TMF leadership, audit readiness, and regulatory compliance roles.
๐ Job Overview โ Senior TMF Analyst
The Senior TMF Analyst acts as a bridge between records management teams and clinical project stakeholders, ensuring Trial Master Files are complete, compliant, and audit-ready throughout the study lifecycle.
You will work across multiple clinical projects, ensuring adherence to:
- ICH-GCP guidelines
- Regulatory requirements
- Standard Operating Procedures (SOPs)
๐งพ Key Responsibilities
- Manage TMF documentation lifecycle: filing, indexing, scanning, archiving
- Ensure TMF completeness and inspection readiness
- Coordinate record retrieval, transfer, and storage activities
- Maintain compliance with IQVIA/customer TMF plans and SOPs
- Oversee document imaging and scanning processes
- Train junior staff on records management and TMF processes
- Act as primary contact for internal/external TMF queries
- Support audit and inspection readiness activities
- Monitor data integrity, document accuracy, and compliance metrics
- Lead or support records management projects and teams
๐ Qualifications & Eligibility
- Bachelorโs Degree in Life Sciences / Records Management or related field
- Minimum 4 years experience in:
- TMF management / Records management
- Clinical research documentation
- Strong knowledge of:
- ICH-GCP guidelines
- Regulatory frameworks in clinical trials
- Familiarity with:
- eTMF systems (e.g., Veeva Vault TMF, PhlexTMF)
- Skills required:
- Analytical thinking & problem-solving
- Attention to detail under pressure
- Team leadership & stakeholder communication
- Time and project management
๐ฐ Salary (Estimated)
- โน6 LPA โ โน10 LPA (INR)
(Based on experience, TMF expertise, and location)
๐ Why Join IQVIA?
- Global exposure in clinical trials & TMF operations
- Opportunities to grow into TMF Lead / Study Start-up / Quality roles
- Work on multi-country clinical studies
- Strong focus on compliance, audits, and regulatory excellence
- Career pathway into clinical operations and project management
๐ Job Locations
- Thane, Maharashtra
- Pune, Maharashtra
- Bangalore, India
๐ How to Apply
