TMF Specialist (all levels)

ICON · Chennai, India

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What they're looking for

Bachelor's degree in life sciences, documentation management, or related field
Minimum 3 years clinical research or TMF management experience
Strong knowledge of TMF regulations, guidelines, and best practices
Proficiency with electronic document management systems and TMF software
Excellent organizational, communication, and attention to detail skills
Legal right to work in country where role is based

What you'll be doing

Manage and maintain Trial Master File for assigned clinical trials
Ensure completeness, accuracy, and quality of TMF documents throughout trial lifecycle
Collaborate with study teams on timely collection, processing, and filing of essential documents
Conduct TMF audits and inspections for regulatory compliance and sponsor requirements
Provide guidance and support on TMF matters to internal stakeholders

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