Fortrea is seeking a TMF Associate I in Bangalore to manage document classification under Smart Inbox and ARC review, ensuring compliance with regulatory requirements. This role is critical in maintaining the Trial Master File (TMF) for clinical studies, ensuring audit readiness, and supporting quality and compliance in clinical research.
Key Responsibilities
- Manage electronic Trial Master Files (eTMF) for clinical studies, ensuring proper classification and organization of Trial, Country, and Site artifacts.
- Perform visual quality checks on e-documents to confirm clarity and readability before release.
- Conduct Audit Ready Checks (ARC) on documents in the eTMF system to ensure accuracy and compliance.
- Maintain audit readiness by adhering to company SOPs, sponsor SOPs, GCP, and ICH guidelines.
- Identify and resolve operational issues related to the TMF.
- Prepare TMF for QA audits and assist in implementing corrective actions.
- Participate in internal and client audits as required.
- Collaborate with cross-functional teams to ensure client satisfaction and study success.
- Support business improvement initiatives to enhance quality, productivity, and efficiency.
- Attend study team meetings (internal/external) as needed.
Qualifications & Experience
Minimum Requirements:
- Bachelor’s degree in Life Sciences/Business or related field.
- 6-12 months of experience in a clinical research environment.
- Strong understanding of GCP, ICH guidelines, and regulatory document requirements.
- Proficiency in Microsoft Office, Adobe Acrobat, and web-based applications.
- Excellent interpersonal and organizational skills.
Preferred Qualifications:
- Master’s degree in Life Sciences/Business.
- Experience working with clinical electronic systems.
Work Environment & Travel
- Full-time position based in Bangalore.
- Minimal travel (<10%) for client meetings or kick-offs.
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) dedicated to advancing clinical trials and drug development. We provide innovative solutions to biopharmaceutical companies, ensuring compliance, efficiency, and quality in clinical research.
At Fortrea, we foster a collaborative and inclusive work environment, empowering employees to contribute to life-changing medical breakthroughs.
