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TMF Associate I - Job Opportunity at Fortrea

Bengaluru, India
Full-time
Entry-level
Posted: May 1, 2025
On-site
INR 400,000 - 600,000 per year based on Bengaluru market rates for entry-level clinical research positions

Benefits

Comprehensive clinical research industry exposure
Professional development opportunities in regulatory compliance
Global team collaboration experience

Key Responsibilities

Manage electronic Trial Master Files (eTMF) including trial, country and site artifacts
Ensure regulatory compliance and audit readiness through document quality control
Collaborate with global study teams and stakeholders
Participate in internal and external audits
Drive continuous process improvement initiatives

Requirements

Education

Bachelor's Degree with a Life Sciences/Business focus

Experience

6-12 months in clinical research environment

Required Skills

GCP and ICH guidelines knowledge Microsoft Office proficiency Adobe Acrobat Standard expertise Document management skills Interpersonal skills Regulatory compliance understanding
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Sauge AI Market Intelligence

Industry Trends

Clinical trial digitization is driving increased demand for eTMF specialists as organizations transition from paper-based systems. Regulatory compliance requirements are becoming more stringent, particularly in emerging markets like India. Contract Research Organizations (CROs) are expanding their presence in Asia-Pacific regions, creating opportunities for clinical research professionals.

Role Significance

Typically part of a 5-10 member TMF team supporting multiple clinical trials
Entry-level position with significant responsibility for maintaining critical trial documentation and regulatory compliance

Key Projects

Clinical trial documentation management Regulatory compliance audits Process improvement initiatives Electronic system implementation support

Success Factors

Strong attention to detail and quality control mindset Ability to work effectively in a regulated environment Understanding of clinical research processes and terminology Excellent documentation and organization skills

Market Demand

High demand due to increasing clinical trial activities in India and growing emphasis on digital documentation compliance

Important Skills

Critical Skills

Regulatory compliance knowledge is fundamental as it directly impacts trial validity and approval processes Document management expertise ensures trial data integrity and audit readiness Technical proficiency with eTMF systems is essential for modern clinical trial operations

Beneficial Skills

Project management capabilities enhance career growth opportunities Understanding of clinical trial processes beyond documentation Knowledge of global regulatory requirements Experience with multiple eTMF platforms

Unique Aspects

Role combines traditional clinical documentation expertise with modern electronic system management
Position offers exposure to global clinical trials while working from India
Opportunity to develop expertise in emerging digital clinical trial management systems

Career Growth

Typical progression to Senior TMF Associate within 2-3 years with demonstrated expertise

Potential Next Roles

Senior TMF Associate TMF Lead Clinical Documentation Specialist Regulatory Affairs Specialist

Company Overview

Fortrea

Fortrea is a major global Contract Research Organization (CRO) providing clinical research and trial management services to pharmaceutical companies

Significant player in the global CRO market with strong presence in clinical trial management
Strategic expansion in India with Bengaluru serving as a key operational hub
Process-driven environment with emphasis on quality and compliance, typical of regulated clinical research organizations
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