Job Overview:
Responsible for general maintenance and any required archival of documents produced by the CPS Project Management (PM) Team. Organizing, gathering, scanning, and filing of all applicable documents into appropriate electronic and/or paper copy locations, including the Trial Master File (TMF), as directed by Fortrea SOPs or other applicable directive. Responsible for filing TMF documents for CPS PM, Non-Fortrea sites, and the Fortrea P1MS Clinical Monitoring Team. Responsible for document query generation and file reconciliation/resolution activities to support delivery of the TMF to client quality and integrity specifications, as well as to meet project timelines and productivity targets.

Summary of Responsibilities:
- Proactively maintains an internal standardized filing structure for study-related documents, as well as departmental files, which may include non-project-specific sponsor files.
- Creates and/or maintains any general document/file-related tracking forms and/or spreadsheets, as applicable.
- Gathers, organizes, scans, and ships project documentation,



as required.
- Assists in the review and finalization of the TMF Plan and Index for individual projects.
- May assist the PC/PM in project setup activities around TMF (e.g., TMF account request, TMF
- Specialist request, etc.), as well as TMF closeout processes.
- Takes ownership for maintaining the TMF (Fortrea /Client systems) by working with applicable project team members to retrieve, file, and upload documents in accordance with applicable project milestones/timelines, SOPs, policies, system, and client requirements.
- Interacts directly with project teams in securing documents for the TMF, as well as for follow[1]up regarding missing documents, as appropriate; actively monitors and performs document quality checks, identifying, tracking, and following up on document quality issues with relevant staff members.
- Works with the PM/PC involved project teams, and applicable business partner

📌 Document Specialist Ii (Bengaluru)
🏢 Fortrea
📍 Bengaluru