Are you passionate about clinical research and ready to make the impossible possible? Fortrea, a leading global CRO, is seeking a dedicated TMF Classifier I to join our Bangalore team in a hybrid role. At Fortrea, we’re a family united by a shared commitment to excellence, transforming lives through groundbreaking clinical trials. If you’re looking for a career that blends purpose, teamwork, and growth, this is your chance to shine. Apply by August 8, 2025, and embark on a journey to deliver exceptional results in clinical research.
Job Overview
As a TMF Classifier I, you’ll play a pivotal role in managing electronic Trial Master Files (eTMF) for clinical studies, ensuring compliance with regulatory standards and audit readiness. Based in Bangalore, this hybrid role offers flexibility and collaboration with global teams, making it ideal for professionals with a passion for clinical research and document management.
Key Responsibilities
- Manage eTMF Processes: Oversee Trial, Country, and Site artifacts in accordance with TMF processes, collaborating with study teams and startup members.
- Document Classification and Review: Handle document classification under Smart Inbox, perform ARC reviews, and manage document deletion as needed.
- Ensure Audit Readiness: Conduct visual quality checks on e-documents for clarity and readability, and perform Audit Ready Checks to ensure accurate context in the eTMF system.
- Track Essential Artifacts: Process and track final essential documents throughout all study phases, adhering to company SOPs, sponsor SOPs, GCP, and ICH guidelines.
- Support Audits: Prepare TMF for QA or sponsor audits, identify operational issues, and implement corrective actions based on audit findings.
- Collaborate for Success: Work closely with Business Process and Study teams to ensure client satisfaction and drive continuous improvement.
- Attend Meetings: Participate in internal or external study team meetings as required to support project goals.
- Contribute to Improvement: Engage in business improvement initiatives to enhance quality, productivity, and processes.
Qualifications
Minimum Required:
- Education: Bachelor’s Degree with a focus on Life Sciences or Business.
- Experience: 6–12 months in a clinical research environment.
- Knowledge: Clear understanding of GCP and ICH guidelines, and regulatory/clinical document requirements.
- Skills: Proficiency in Microsoft Office, web-based applications, and Adobe Acrobat Standard. Excellent interpersonal skills.
Preferred Qualifications:
- Education: Master’s Degree in Life Sciences or Business.
- Experience: Equivalent clinical research experience (6–12 months) may substitute for education requirements.
- Technical Skills: Experience with clinical electronic systems is a plus.
Benefits of Joining Fortrea
- Career Growth: Embark on a rewarding career journey with opportunities for professional development in clinical research.
- Hybrid Work Model: Enjoy the flexibility of a hybrid role based in Bangalore, balancing remote and office work.
- Team-Oriented Culture: Join a supportive, family-like environment where teamwork drives extraordinary results.
- Impactful Work: Contribute to life-changing clinical trials that advance global healthcare.
- Minimal Travel: Less than 10% travel for sponsor kick-off or client meetings, ensuring work-life balance.
How to Apply
