Senior TMF Analyst

IQVIA

Liaison between Records Management and user departments handling Trial Master files. Ensuring compliance with regulatory guidelines and project timelines at IQVIA.

Posted 6/9/2026full-timeThane • 🇮🇳 IndiaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as the liaison between Records Management and user departments regarding Trial Master files
Review essential clinical documents to ensure they meet ALCOA++ principles, ICH-GCP guidelines, and Good Documentation Practices (GDP)
Uploads, classifies, and verifies document metadata to ensure easy retrieval
Review files against the Expected Document List (EDL) to identify missing pages or files
Maintain the eTMF in a permanent state of inspection readiness, supporting study teams and regulatory authorities
Work closely with CRAs, TMF managers, and cross-functional study teams
Ensure project timelines are met and facilitate orderly transfer, imaging, scanning, retention, and disposition of records
Train team members on records management tasks, policies, and procedures
Serve as primary contact for internal and external clients

Requirements

What you’ll need

Bachelor's Degree in Records management or related field
At least 5 years' experience working in a Records Management technically-related area
Strong knowledge of applicable research and regulatory requirements, i.e., ICH, GCP and local laws
Knowledge of technology applications relevant to records management environments
Ability to perceive and analyze problems, develop solutions, and make sound decisions
Ability to handle multiple tasks and projects and balance competing priorities
Excellent oral and written communication skills, including good command of English
Ability to establish and maintain effective working relationships with clients
Ability to lead others

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development
Equipment allowances

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Records ManagementALCOA++ principlesICH-GCP guidelinesGood Documentation PracticeseTMFdocument metadata managementExpected Document Listimagingscanningretention and disposition of records

Soft Skills

problem analysissolution developmentdecision makingmultitaskingproject managementoral communicationwritten communicationrelationship buildingleadership

Certifications

Bachelor's Degree in Records Management