Document Specialist II

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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.

Qualifications (Minimum Required):

Lifescience graduate with 1 - 2 years of relevant experience
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Language Skills Required: Speaking: English Writing/Reading: English

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-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.

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.

Required Experience:

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)...