Clinical Project Assistant
SanofiÂ
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Job Description
Location: Bangalore, India (Hybrid)
Job Requisition ID: 254865
Job Type: Full-time
Application Deadline: October 10, 2025
About the Role
Fortrea is seeking a Records Management Associate to support the maintenance and organization of both paper and electronic trial documentation within the electronic Trial Master File (eTMF) system. The role ensures compliance with ICH-GCP guidelines, regulatory standards, and company procedures while providing support in the archiving, indexing, and retrieval of clinical records.
This position is ideal for candidates with strong attention to detail, a background in life sciences or records management, and a desire to contribute to efficient and compliant clinical research documentation processes.
Role & Responsibilities
- Maintain and manage paper and electronic documents for the eTMF in accordance with applicable regulations and internal guidelines.
- Collect, index, and store newly received documents while ensuring accuracy and completeness.
- Support migration of paper documents into electronic systems and maintain data integrity.
- Retrieve and archive records, ensuring secure and organized storage.
- Perform quality checks on document attributes to meet compliance and audit readiness standards.
- Use imaging and quality-control applications to support eTMF maintenance.
- Respond to complex records management queries and assist with audits and inspections.
- Train team members and lead document management projects with minimal supervision.
- Maintain an updated archive database, enabling efficient document retrieval and tracking.
- Contribute to process improvement initiatives to enhance departmental efficiency.
Educational Qualification
- Bachelor’s degree in Life Sciences, Records Management, or Library Sciences.
- Equivalent relevant experience may be considered in lieu of educational requirements.
  Experience & Skills
- Minimum 2 years of experience in a records management or clinical documentation environment.
- Strong knowledge of Regulatory and Clinical trial documents.
- Understanding of record retention requirements for the pharmaceutical industry.
- Experience with clinical electronic systems and ICH/GCP guidelines.
- Proficiency in Microsoft Office, web-based applications, and Adobe Acrobat Standard.
- Strong analytical, organizational, and interpersonal skills.
- Ability to work independently and handle multiple projects simultaneously.
- Excellent communication skills with a focus on quality and compliance.
Location
 Bangalore, India (Hybrid)
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