Document Specialist II

Fortrea Development India; Bengaluru; On-site; INR 300,000 - 500,000; Full time

Job summary

Fortrea Development India is seeking a Document Specialist to manage TMF-related filing and archival tasks for CPS PM teams in Bengaluru. You will organize, scan, and file study documents into Fortrea systems and client TMFs, ensuring accuracy and timeliness.

The role requires strong English communication, proficiency with Adobe Acrobat and MS Office, and meticulous attention to document quality. You will train junior staff and support TMF closeout activities as needed.

Qualifications

• High School Diploma or equivalent required; BS in a scientific field preferred if available.
• Proficiency in English communication (written and spoken) is required.
• Experience with document management and archiving processes is desirable.

Responsibilities

• Maintain internal standardized filing structure for study documents and departmental files.
• Create and maintain general document/file tracking forms/spreadsheets.
• Gather, organize, scan, and ship project documentation as required.
• Assist in review and finalization of TMF Plan and Index for projects.
• Assist TMF setup and closeout processes as applicable.
• Maintain the TMF in Fortrea/Client systems with milestone-driven filing.
• Interact with project teams to secure documents and perform quality checks.
• Support TMF reconciliation as part of quality control.
• Generate copies of project data for archival or client delivery.
• Lead archiving duties for paper and electronic media.
• Provide data to management on compliance metrics; train new DS team members.
• Act as TMF Subject Matter Expert and train others in eTMF systems.

Skills

English communication

Organizational skills

Attention to detail

Documentation

Education

High School Diploma or equivalent

BS in scientific field preferred

Tools

Adobe Acrobat

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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 partners for reconciliation of the TMF as part of the quality control process.
• May generate copies of project data and other project information on various electronic media for archival and/or to provide to the PM or PC for client delivery.
• Leads and performs archiving duties for paper and/or electronic media, as needed.
• May provide departmental management teams with metric data within areas of expertise, as needed, to show compliance with applicable processes; performs other departmental or project administrative tasks, as assigned.
• Trains and mentors new Document Specialists in all aspects of the role; responsible for routine development/review/revision of DS training materials.
• TMF Subject Matter Expert; trains new document specialists and other team members in the use of various eTMF systems/processes, as needed.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• High School Diploma or equivalent at minimum.
• BS or equivalent in scientific field preferred.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required: Speaking: English Writing/Reading: English

Experience (Minimum Required):

• Strong written and verbal communication skills (English language).
• Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, Power Point).
• Strong organizational skills, with the ability to work in a fast-paced setting with many interruptions.

Physical Demands/Work Environment:

• Must be able to sit at a computer for long periods of time.
• Must be able to use hands to finger, handle or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day.
• Standard office and/or home working environment.
• Risk of eye strain.
• Will involve out of normal office hours as required by the role.

Learn more about our EEO & Accommodations request here .