Are you passionate about clinical trials and looking for a meaningful role in the healthcare industry? Fortrea, a leading global contract research organization (CRO), is hiring for the position of TMF Reviewer II in Bangalore.
About Fortrea
Fortrea combines scientific rigor with decades of clinical development expertise to deliver cutting-edge solutions in pharmaceuticals, biotechnology, and medical devices. Operating across more than 100 countries, we are dedicated to transforming drug and device development for the benefit of patients worldwide.
Job Description: TMF Reviewer II
The TMF Reviewer II is a critical role responsible for the management, review, and quality control of clinical trial documents within the electronic Trial Master File (eTMF) system. This includes ensuring compliance with regulatory requirements, maintaining audit readiness, and supporting clinical study teams.
Key Responsibilities
- Document Management: Oversee eTMF activities for Phase I-IV clinical studies, including document classification, ARC review, and quality checks.
- Audit Readiness: Ensure eTMF is always prepared for audits by performing audit-ready checks and resolving findings.
- Compliance and Quality Control: Track and obtain missing or incomplete documents, ensuring adherence to Labcorp SOPs, sponsor SOPs, GCP, and ICH guidelines.
- Issue Resolution: Address and resolve operational issues related to the TMF, identifying trends and implementing corrective actions.
- Collaboration: Work closely with project teams, global quality control teams, and sponsors to ensure successful study outcomes.
- Client Interaction: Support status reports for clients, prepare TMFs for audits, and participate in client meetings.
- Continuous Improvement: Contribute to business improvement initiatives to enhance quality and productivity.
Qualifications and Skills
- Education and Experience: Relevant experience in clinical trial documentation and TMF management is required.
- Regulatory Knowledge: Understanding of GCP, ICH guidelines, and applicable regulatory requirements.
- Attention to Detail: Strong organizational skills to manage documentation accuracy and completeness.
- Problem-Solving: Ability to identify issues and implement effective solutions.
- Collaboration: Excellent interpersonal and communication skills for working with cross-functional teams.
Why Join Fortrea?
- Innovative Environment: Be part of a team revolutionizing clinical trials.
- Professional Growth: Opportunities for learning, collaboration, and career advancement.
- Global Impact: Contribute to life-changing therapies and ideas that benefit patients worldwide.
- Inclusive Culture: Fortrea values diversity and ensures an equitable workplace for all employees.
