
10,000+ employees
đ„ Healthcare
đ§Ź Biotechnology
đ Pharmaceuticals
Healthcare âą Biotechnology âą Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
đ„ 11 minutes ago
đźđł India â Remote
â° Full Time
đĄ Mid-level
đ Senior
âš Document Specialist
đ» Ghost score 10%
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10,000+ employees
đ„ Healthcare
đ§Ź Biotechnology
đ Pharmaceuticals
Healthcare âą Biotechnology âą Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
âą Maintain and archive documents produced by the CPS Project Management Team âą Organize, gather, scan, file, and ship project documentation âą File TMF documents for CPS PM, non-Fortrea sites, and the Fortrea P1MS Clinical Monitoring Team âą Generate document queries and perform file reconciliation and resolution activities âą Maintain standardized filing structures, departmental files, tracking forms, and spreadsheets âą Assist with TMF Plan and Index review and finalization âą Assist with TMF project setup and closeout processes âą Retrieve, file, and upload documents in accordance with milestones, timelines, SOPs, policies, systems, and client requirements âą Interact with project teams to secure missing TMF documents and follow up on document quality issues âą Perform TMF reconciliation as part of quality control âą Generate copies of project data for archival or client delivery âą Lead and perform paper and electronic archiving duties âą Provide metric data and perform departmental or project administrative tasks âą Train and mentor new Document Specialists and develop, review, and revise training materials âą Serve as a TMF Subject Matter Expert and train team members on eTMF systems and processes âą Perform other duties as assigned
âą High School Diploma or equivalent at minimum âą BS or equivalent in scientific field preferred âą Fortrea may consider relevant and equivalent experience in lieu of educational requirements âą Strong written and verbal communication skills in English âą Experience working with computers and basic programs, including Adobe Acrobat, Word, Excel, and PowerPoint âą Strong organizational skills and ability to work in a fast-paced setting with many interruptions âą Must be able to sit at a computer for long periods âą 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 âą Risk of eye strain
âą Remote work arrangement âą Standard office and/or home working environment âą Training and mentoring opportunities âą Opportunity to train and mentor new Document Specialists âą Potential work outside normal office hours as required by the role
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