If you’re an experienced clinical research professional looking to grow in the field of documentation and compliance, this TMF Reviewer I role at Fortrea is a fantastic opportunity! 🚀 With increasing demand for well-managed clinical trial documentation, TMF roles are becoming highly valuable across the pharmaceutical industry.
Let’s explore this opportunity in detail 👇
🏢 About Fortrea
Fortrea is a leading Contract Research Organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies in conducting clinical trials and bringing new treatments to market. 🌍💊
The company operates globally and is known for delivering high-quality clinical development solutions, including:
- Clinical Operations
- Data Management
- Regulatory Support
- TMF & Documentation Services
👉 In India, Bangalore is one of the major hubs where Fortrea hires skilled professionals for clinical roles.
🧾 Job Overview
The TMF Reviewer I is responsible for reviewing and managing electronic Trial Master Files (eTMF) to ensure all documents are accurate, complete, and compliant with regulatory standards.
💼 Job Type: Full-Time
🏢 Work Mode: Hybrid
📍 Location: Bangalore
This role offers a balance of flexibility and collaboration—ideal for professionals who want both structure and autonomy.
🎯 Key Responsibilities
📂 TMF Review & Management
- Review eTMF documents across trial, country, and site levels
- Classify and organize documents as per TMF structure
- Perform Audit Ready Checks (ARC)
🔍 Quality & Compliance
- Ensure compliance with GCP (Good Clinical Practice) and ICH guidelines
- Conduct visual checks for document quality and completeness
- Maintain TMF in an audit-ready state
📊 Documentation Tracking
- Track essential documents across all study phases
- Map sponsor TMF index with internal standards
- Perform QC checks in sponsor systems
🤝 Collaboration
- Coordinate with study teams, sponsors, and QA teams
- Participate in audits and meetings
- Support ongoing project activities
📈 Continuous Improvement
- Identify process gaps and suggest improvements
- Assist in training and mentoring
- Contribute to workflow enhancements
🎓 Qualifications Required
- 🎓 Bachelor’s Degree in Life Sciences or related field
- 📚 Strong knowledge of:
- GCP & ICH Guidelines
- Clinical documentation standards
- Regulatory compliance
- 💻 Familiarity with:
- Microsoft Office
- eTMF systems
- Adobe Acrobat
💼 Experience Required
- ⏳ 4 to 8 years in clinical research
- Experience in TMF review / documentation preferred
⭐ Preferred Qualifications
- 🎓 Master’s Degree (Life Sciences / Business)
- 💡 Experience with clinical electronic systems
- 🔄 6–10 years experience may substitute higher education
🌍 Work Details
- 📍 Location: Bangalore
- 🏢 Mode: Hybrid
- ✈️ Travel: Minimal (less than 10%)
💡 Why Join Fortrea?
✨ Global Exposure
Work with international sponsors and large-scale trials
📈 Career Growth Opportunities
- TMF Lead
- Clinical Project Manager
- Quality Assurance Specialist
🔬 Industry-Relevant Skills
Hands-on exposure to compliance, audits, and regulatory frameworks
⚠️ Important Note
Like most CROs, workload and work culture can vary depending on the project and team. Always clarify expectations during interviews for better alignment.
⏳ Application Deadline
📅 Last Date to Apply: March 31, 2026
⏰ Don’t miss out—apply as soon as possible!
🚀 Final Thoughts
The TMF Reviewer I role at Fortrea is an excellent opportunity for professionals aiming to specialize in clinical documentation and regulatory compliance.
If you are detail-oriented, organized, and passionate about clinical research quality standards, this role can significantly elevate your career in the CRO industry. 💼✨
