Manager - TMF Operations

ICON · Chennai, India

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What they're looking for

Bachelor's degree in life sciences, documentation management, or related field
Extensive TMF management or clinical operations experience in pharmaceutical/clinical research
Deep knowledge of GCP, ICH guidelines, and global regulatory requirements
Proven team leadership and development experience in regulated environments
Proficiency with electronic TMF systems and document management tools
Strong project management skills across multiple concurrent clinical studies
Willingness to travel approximately 25% as required

What you'll be doing

Oversee TMF operations team and manage trial master file across multiple clinical studies
Ensure collection, review, and timely filing of essential documents throughout trial lifecycle
Collaborate with clinical operations, regulatory affairs, and quality assurance teams
Develop and implement TMF management strategies, policies, and procedures
Monitor quality metrics, identify improvements, and prepare TMF for regulatory audits

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