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Fortrea, a global leader in clinical research and biopharmaceutical solutions, is hiring a Records Management Associate to support the maintenance, organization, and compliance of regulatory and clinical documentation.
If you have experience managing clinical trial records, eTMF systems, and ICH/GCP guidelines, this role offers a dynamic environment with opportunities for growth and professional development.
📋 Key Responsibilities
As a Records Management Associate, you will:
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- Maintain paper and electronic records in compliance with regulatory and legal standards.
- Manage and organize documents within the electronic Trial Master File (eTMF).
- Assist in migrating paper documents to digital systems.
- Conduct quality checks to ensure accuracy and completeness of data.
- Maintain archives, track records, and ensure quick retrieval of documents.
- Support client and regulatory inspections, explaining document processes.
- Train team members and lead projects independently.
- Work cross-functionally with clinical, regulatory, and quality teams.
🎓 Required Qualifications
- Bachelor’s Degree in Life Sciences, Records Management, or Library Sciences.
- Minimum 2 years of experience in a records management or regulatory documentation role.
- Strong understanding of ICH/GCP guidelines and pharma record retention requirements.
- Proficiency in Microsoft Office, Adobe Acrobat, and clinical electronic systems.
- Excellent communication, organizational, and interpersonal skills.
💼 Preferred Experience
- Prior experience in clinical document management systems (eTMF).
- Experience managing regulatory submissions or trial documentation.
- Ability to work independently with minimal supervision.
- Strong analytical and documentation skills with attention to detail.
🌎 Work Environment & Travel
- Location: Bangalore, India (Hybrid)
- Light travel (approximately 5%) to client or vendor locations.
- Ability to lift archive boxes up to 25 lbs occasionally.
💰 Salary Range
- Estimated Salary: ₹6,00,000 – ₹10,00,000 per annum (based on experience).
🕒 Application Deadline
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