If you’re looking to build a strong career in clinical research documentation and trial management, this opportunity could be a great fit. Teamware Solutions is currently hiring eTMF Document Specialists for its Bengaluru location. This role focuses on Trial Master File (TMF) operations, compliance, and audit readiness—making it ideal for professionals with experience in clinical documentation.
🏢 About the Company
Teamware Solutions is a well-established IT services and consulting firm supporting industries like healthcare and life sciences. The company works closely with global clients, providing expertise in clinical documentation, compliance, and data management.
This role offers exposure to advanced clinical technologies, especially electronic Trial Master File (eTMF) systems.
📍 Job Location
Bengaluru 🌆
📊 Job Overview
- Role: eTMF Document Specialist
- Level: Associate
- Openings: 15 vacancies
- Employment Type: Full-Time (Contractual/Temporary)
- Industry: Healthcare & Life Sciences
This is a high-demand role within clinical operations, especially for professionals experienced in TMF and regulatory documentation.
🎓 Eligibility Criteria
- Education: Any Graduate (Life Sciences preferred)
- Experience: Prior experience in TMF/eTMF documentation in clinical trials
🛠️ Must-Have Skills
- eTMF / TMF Documentation
- Hands-on experience with Veeva Vault eTMF
- Knowledge of International Council for Harmonisation – GCP guidelines
- Understanding of Good Documentation Practices (GDP)
- Familiarity with ALCOA++ principles
➕ Good-to-Have Skills
- Clinical Data Management basics
- Understanding of TMF lifecycle
📝 Key Responsibilities
🔍 Quality Control (QC)
- Review TMF documents as per ALCOA++ and regulatory standards
- Ensure accuracy, integrity, and completeness
📤 Document Management
- Upload, index, and classify documents in Veeva Vault eTMF
- Maintain proper metadata and version control
📊 TMF Completeness Checks
- Verify documents at study, country, and site levels
- Compare against Expected Document Lists (EDL)
⚖️ Audit & Inspection Readiness
- Support audits by retrieving documents
- Ensure compliance with regulatory expectations
📈 Tracking & Reporting
- Monitor TMF dashboards and metrics
- Identify gaps and resolve issues
🤝 Collaboration
- Work with CRAs, study teams, and vendors
- Resolve documentation gaps efficiently
🌟 Why This Role is Valuable
- 🌍 Global Exposure: Work with international clinical trial standards
- 📈 Career Growth: Pathways into CTA, TMF Lead, or Clinical Operations
- 🧠 Skill Development: Hands-on experience with Veeva Vault eTMF
- 🏢 High Demand: eTMF specialists are highly sought after in CROs and pharma companies
💡 Tips to Crack This Role
- Highlight TMF/eTMF experience clearly in your CV
- Mention tools like Veeva Vault eTMF or SharePoint
- Be confident with ICH-GCP and ALCOA++ concepts
- Prepare for scenario-based questions (audit readiness, missing docs, QC issues)
📌 Final Thoughts
With clinical trials becoming more complex, proper documentation is critical. This eTMF Document Specialist role in Bengaluru offers a strong foundation in regulatory compliance and clinical operations.
If you are detail-oriented and want to grow in clinical research, this opportunity is worth considering.
