Looking for a career in clinical research documentation or TMF management? Fortrea is hiring for the role of Document Specialist II in India (Bangalore, Pune, Mumbai โ remote/hybrid). This opportunity is ideal for candidates with life sciences backgrounds who want to enter or grow in clinical trial documentation, eTMF systems, and regulatory compliance.
This Document Specialist II job in India offers exposure to global clinical trial operations, Trial Master File (TMF) management, and collaboration with cross-functional project teamsโmaking it a strong entry point into the CRO industry.
๐ Job Overview โ Document Specialist II
The Document Specialist II at Fortrea is responsible for maintaining, organizing, and archiving clinical trial documents, especially within the Trial Master File (TMF). The role ensures that documentation complies with SOPs, regulatory guidelines, and client requirements.
You will work closely with project managers and clinical teams to ensure accurate document tracking, filing, and reconciliation.
๐งพ Key Responsibilities
- Maintain and manage Trial Master File (TMF) and departmental documents
- Organize, scan, file, and archive clinical trial documentation
- Ensure compliance with Fortrea SOPs and regulatory standards
- Perform document quality checks and resolve discrepancies
- Track missing documents and follow up with project teams
- Assist in TMF plan creation, setup, and closeout activities
- Generate document tracking tools (Excel, logs, trackers)
- Support eTMF systems and electronic document uploads
- Participate in TMF reconciliation and audit readiness
- Train and mentor junior document specialists
- Handle archival processes (electronic and paper-based)
๐ Qualifications
- Minimum: High School Diploma (Bachelorโs in Life Sciences preferred โ B.Pharm, M.Pharm, BSc, MSc)
- Strong English communication (written & verbal)
- Basic knowledge of:
- Microsoft Office (Word, Excel, PowerPoint)
- Adobe Acrobat
- Good organizational and multitasking abilities
- Ability to work in a fast-paced clinical environment
๐ผ Preferred Skills
- Knowledge of clinical trials and TMF structure
- Familiarity with eTMF systems (e.g., Veeva Vault, etc.)
- Attention to detail and documentation accuracy
- Experience in document control or clinical operations (optional)
๐ฐ Salary (Estimated)
- โน3.5 LPA โ โน6.5 LPA (based on experience and skills)
๐ Job Location
- India (Remote/Hybrid)
- Bangalore / Pune / Mumbai
๐ Benefits
- Work with a leading global CRO (Fortrea)
- Exposure to clinical research & regulatory documentation
- Opportunity to become TMF Subject Matter Expert
- Career growth in clinical operations, QA, or regulatory roles
- Flexible/remote work environment
๐ฅ How to Apply
