12 Aug
|
Lifelancer
|
Pune
Job Title: Document Specialist II
Job Location: Pune, Maharashtra, India
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level: Entry level
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, S
📌 Document Specialist II (Pune)
🏢 Lifelancer
📍 Pune