Job Overview:
Responsible for performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts and internal Fortrea business needs.

Summary of Responsibilities:
- Position provides process, control, coordination, and approval of clinical trial documents.
- Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
- Maintains an understanding of applicable regulatory requirements.
- Managing electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member.
- Responsible for document classification, ARC review, (when applicable).
- Responsible for performing TMF review. TMF Reviewers may include, but are not limited to, Project Team members, members of Global Quality Control and other reviewers (e.g. Central TMF Reviewers).
- Responsible for mapping the sponsors TMF Index with respect to Fortrea UCV and TMF Review,



if applicable (TMF Reviewers) and responsible for performing QC into Sponsor system (TMF Classifier) if applicable.
- Maintains the TMF in a state of audit readiness for quality and compliance by:
- Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate.
- Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and Index, and study milestones.
- Comply with metrics established for performance TMF reviews.
- Process and track final essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs, GCP and ICH guidelines.
- Manages the identification of operational issues and resolutions related to the TMF.
- Responsible for gathering data requested by stud

📌 TMF Reviewer II (Bengaluru)
🏢 Fortrea
📍 Bengaluru