TMF Reviewer I – Clinical Trial Master File (eTMF) Specialist
Location: Bangalore, India
Job Type: Full-Time | Hybrid
Application Deadline: March 31, 2026
Experience Required: 4–8 years in clinical research, TMF management, or clinical documentation
Job Overview
We are hiring a TMF Reviewer I to support the management and quality review of electronic Trial Master Files (eTMF) across clinical studies. This role is critical in ensuring regulatory compliance, audit readiness, and high-quality documentation aligned with global clinical standards.
The ideal candidate will have hands-on experience in TMF review, document classification, and quality control processes within a clinical research environment, along with a strong understanding of GCP and ICH guidelines.
Key Responsibilities
Manage and review electronic Trial Master Files (eTMF) including trial, country, and site-level documentation
Perform TMF review, document classification, and ARC (Accuracy, Relevance, Completeness) checks
Map sponsor TMF index with internal TMF structures and perform quality control in sponsor systems where required
Ensure all TMF documents meet audit readiness standards through visual quality checks and completeness verification
Track and manage essential clinical documents across all phases of the study in compliance with SOPs, GCP, and ICH guidelines
Identify operational issues within TMF processes and implement appropriate resolutions
Prepare TMF documentation for internal audits, sponsor audits, and regulatory inspections
Participate in audit activities and support corrective and preventive action (CAPA) implementation
Collaborate with cross-functional teams including study teams, quality control, and sponsors
Monitor performance metrics and contribute to continuous process improvement initiatives
Attend study meetings and provide training or mentoring to team members when required
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related field
Strong understanding of GCP, ICH guidelines, and regulatory documentation requirements
Proficiency in Microsoft Office tools and document management systems
Excellent communication and interpersonal skills
Preferred Qualifications
Master’s degree in Life Sciences or Business-related discipline
Experience working with eTMF systems and clinical trial electronic platforms
Hands-on experience with document classification, QC processes, and audit readiness activities
Strong analytical and problem-solving capabilities
Work Environment and Expectations
Hybrid work model based in Bangalore
Minimal travel requirement (less than 10%) for sponsor meetings or client interactions
Collaborative and quality-focused clinical research environment
Why Apply
This role offers a strong opportunity to work on global clinical trials, enhance expertise in eTMF management, and contribute to regulatory compliance and audit readiness within a fast-paced clinical research setting.
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