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TMF Classifier I

BANGALORE (IN)HYBRIDPOSTED: 7/7/2026
PHARMAFull-time
HIRING ORGANIZATIONFORTREAContract Research Organization (CRO) / Biosciences / Healthcare
Fortrea

ROLE DEFINITION & RESPONSIBILITIES

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.

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.

REQUIRED VERIFIED SKILLS

GCP
ICH guidelines
Clinical document requirements
Microsoft Office
Adobe Acrobat Standard

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Compensation packages for entry-level clinical research data and documentation positions in Bangalore are typically competitive and aligned with industry standards for global CROs. Package components usually include a base salary plus standard corporate health and wellness benefits.

ORGANIZATION CONTEXT & CULTURE

Fortrea is a global contract research organization (CRO) providing comprehensive clinical development, patient access, and laboratory services. Spun off from Labcorp in 2023, Fortrea partners with pharmaceutical, biotech, and medical device companies to accelerate the development and commercialization of new therapies. They offer a full suite of services across the entire drug development lifecycle.

TEAM SIZE: 19,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Biosciences / Healthcare

EXPECTED CAREER ROADMAP

This entry-level role within a leading global Contract Research Organization (CRO) like Fortrea provides an excellent foundation for a long-term career in clinical research operations. Document management in the Trial Master File (TMF) space exposes professionals to global trial documentation, which can lead to advanced roles such as TMF Lead, TMF Lead Manager, Clinical Trial Associate (CTA), or roles within Clinical Data Management and Quality Assurance.

APPLICATION ADVISORY

To stand out for this position, candidates should strongly highlight their foundational knowledge of Good Clinical Practice (GCP) and ICH guidelines in their resume. Demonstrating familiarity with clinical trial structures (Trial, Country, and Site levels) and highlighting any internship or prior 6-12 month experience with electronic clinical systems or rigorous documentation standards will be highly advantageous.
RECOMMENDED TRAINING
1/5
Clinical Research Starter Kit

Clinical Research Starter Kit

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