R&D eTMF Document Specialist – Hyderabad, India
Company: Sanofi
Job Type: Full-time
Department: R&D / Clinical Operations
The R&D eTMF Document Specialist is a critical contributor to Sanofi’s clinical development operations. This role ensures the accuracy, quality, and regulatory compliance of the Trial Master File (TMF) throughout the lifecycle of clinical studies. The specialist works closely with TMF Managers, Clinical Operations Study Leaders (COSLs), Global Study Leaders (GSLs), country-level teams, and site monitors to support documentation integrity and inspection readiness.
This position requires strong organizational skills, attention to detail, and the ability to collaborate across global, cross-functional environments.
Manage TMF documentation in alignment with internal SOPs, ICH-GCP, and regulatory requirements.
File documents in the eTMF system, ensuring metadata accuracy and consistent quality control.
Create, track, and follow up on user tasks within the eTMF system.
Conduct file reviews and Expected Document List (EDL) checks in coordination with the TMF Manager.
Ensure consistency and completeness of study documents at study, country, and site levels.
Share EDL updates with COSLs and COSCLs, and follow up with teams to resolve document issues.
Perform independent QC of documents filed in the eTMF.
Verify correct indexing and classification of documents.
Coordinate corrections, manage document queries, and escalate recurring issues.
Support TMF Contributors with system guidance and documentation best practices.
Maintain continuous inspection readiness across all assigned studies.
Assist in audit and regulatory inspection preparation.
Facilitate timely document retrieval during inspections.
Participate in process improvement initiatives related to TMF management.
Contribute to eTMF system enhancements, testing activities, and process improvements.
Track and report TMF quality indicators and performance metrics.
Collaborate with study teams, TMF managers, CROs, and vendors on TMF-related matters.
Support development of TMF-related training materials and SOPs.
Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
Experience in eTMF management or clinical documentation is an advantage.
Knowledge of ICH-GCP, clinical research processes, and regulatory expectations.
Experience with electronic TMF systems; Veeva Vault experience is preferred.
Strong attention to detail, documentation accuracy, and organizational skills.
Excellent written and verbal communication skills in English.
Ability to work independently and collaboratively within cross-functional teams.
Strong problem-solving ability, analytical mindset, and customer service orientation.
Adaptability to new processes, tools, and fast-paced environments.
Sanofi is a global leader in scientific innovation, merging advanced research with digital and AI-powered technologies. The organization offers opportunities to expand expertise, grow as a leader, and contribute to groundbreaking scientific work across oncology, vaccines, neurology, and rare diseases.
Sanofi is deeply committed to diversity, equity, and inclusion, ensuring equal opportunities for all employees.
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