Document Specialist II

Job not on LinkedIn

đŸ”„ 11 minutes ago

🇼🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✹ Document Specialist

đŸ‘» Ghost score 10%

infoinfo
Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of Fortrea

Fortrea

10,000+ employees

đŸ„ Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare ‱ Biotechnology ‱ 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.

📋 Description

‱ Maintain and archive documents produced by the CPS Project Management Team ‱ Organize, gather, scan, file, and ship project documentation ‱ File TMF documents for CPS PM, non-Fortrea sites, and the Fortrea P1MS Clinical Monitoring Team ‱ Generate document queries and perform file reconciliation and resolution activities ‱ Maintain standardized filing structures, departmental files, tracking forms, and spreadsheets ‱ Assist with TMF Plan and Index review and finalization ‱ Assist with TMF project setup and closeout processes ‱ Retrieve, file, and upload documents in accordance with milestones, timelines, SOPs, policies, systems, and client requirements ‱ Interact with project teams to secure missing TMF documents and follow up on document quality issues ‱ Perform TMF reconciliation as part of quality control ‱ Generate copies of project data for archival or client delivery ‱ Lead and perform paper and electronic archiving duties ‱ Provide metric data and perform departmental or project administrative tasks ‱ Train and mentor new Document Specialists and develop, review, and revise training materials ‱ Serve as a TMF Subject Matter Expert and train team members on eTMF systems and processes ‱ Perform other duties as assigned

🎯 Requirements

‱ 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 ‱ Strong written and verbal communication skills in English ‱ Experience working with computers and basic programs, including Adobe Acrobat, Word, Excel, and PowerPoint ‱ Strong organizational skills and ability to work in a fast-paced setting with many interruptions ‱ Must be able to sit at a computer for long periods ‱ 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 ‱ Risk of eye strain

đŸ–ïž Benefits

‱ Remote work arrangement ‱ Standard office and/or home working environment ‱ Training and mentoring opportunities ‱ Opportunity to train and mentor new Document Specialists ‱ Potential work outside normal office hours as required by the role

Apply Now