Fortrea

Document Specialist II (seeking immediate joiners or with notice period less than 30 days)

India · Remote (restrictions not stated) · Full time

Apply on the employer’s site ↗See how well you match this job

You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.

About the role

Description from the employer’s posting. Check the employer’s page for the current version.

  • EmployerFortrea
  • LocationIndia
  • Work styleRemote (restrictions not stated)
  • Employment typeFull time
  • Employer posted

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.

Show full description

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):

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):

2 years of relevant experience in TMF activities

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.

Staying safe while you apply

  • Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
  • Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
  • Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.

Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.

Preparing for this role with ROLIVA

  • Check the fit.

    Compare the requirements with the experience you have confirmed, including gaps.

  • Prepare honestly.

    Build interview stories and application drafts from your own evidence.

  • Keep track.

    Save the role and record your own application status and follow-ups.

Create a free workspace or log in.

At a glance

  • Work styleRemote (restrictions not stated)
  • Employment typeFull time
  • Employer posted
  • Added to ROLIVA
  • Last checked

Skills in this posting

Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.

Excel

Explore similar roles

Similar jobs