Roles & Responsibilities
• Collaborate with the eTMF Team Lead to proactively meet TMF business and study requirements
• Act as document creator, QC reviewer, and primary TMF contact for assigned clinical studies
• Manage end-to-end TMF activities including document processing, indexing, filing, and reconciliation
• Ensure continuous TMF completeness, accuracy, and inspection readiness
• Perform discrepancy identification and resolution as per SOPs, timelines, and regulatory expectations
• Support internal audits and external regulatory inspections
• Contribute to TMF-related SOPs, guidelines, and system user documentation
• Communicate TMF risks, issues, and status updates to senior stakeholders in a timely manner
Qualification
• Degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline
Experience
• 1-3 years of hands-on experience in eTMF, TMF operations, or clinical documentation roles
Skills
• Strong knowledge of ICH-GCP guidelines and TMF lifecycle management
• Understanding of regulatory inspection preparedness and compliance requirements
• High attention to detail with a strong quality and audit-focused mindset
• Good communication skills and ability to collaborate with cross-functional clinical teams
About the Company
Tata Consultancy Services (TCS) is a global leader in IT services, consulting, and life sciences solutions, supporting pharmaceutical and clinical research organizations worldwide with technology-driven, compliant, and scalable solutions across clinical operations, regulatory affairs, and digital transformation.