Job Overview:

Manages and supports the study TMF right from the study set up to the closeout, including the transfer of the TMF. Managing study TMF health and completeness. Responsible for initiating the Review workflow.

Summary of Responsibilities:
- The position provides process, control, coordination, and approval of clinical trial documents.
- The position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
- Is the primary TMF Delivery Center point person for assigned studies.
- Conduct TMF-specific Kick-off Meeting with Sponsor and Fortrea project team to establish expectations, requirements and deliverables in line with ICH and to support scope build.
- Oversees the planning, set-up, maintenance, QC, and closure of the study TMF for clinical studies, in accordance with agreed TMF processes (Fortrea or sponsor SOPs) working with key study personnel as identified.
- Confirms internal and external system access needs.




- Accountable for the creation and maintenance of the TMF Plan and TMF Index in collaboration with the Project Manager/Project Lead and Sponsor.
- Maintenance of access within the TMF system in collaboration with the TMF access management team.
- Compliance with current Fortrea eTMF system training requirements. Where needed, complete required eTMF system training for sponsor systems.
- Provide project team training on study specific TMF plan and Index or other Trainings, as required.
- Ensure deviations from standard Fortrea TMF business process and operating model are documented accordingly in TMF Plan or other applicable document.
- Document and escalate all identified compliance issues. Follow-up findings until resolution/CAPA implementation.
- Monitor project scope and communicate any identified out-of-scope activity or requests to the Project Lead.
- Receive sponsor-specific report requests (confirm required, within scope). Work with appropriate TMF operational services and TMF system experts to evaluate the feasibility

📌 TMF lead II (Bengaluru)
🏢 Fortrea
📍 Bengaluru