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Vacancy description

Manager - TMF Operations in Chennai, भारत

ICON

Chennai, भारत

Manager overseeing Trial Master File (TMF) operations and compliance across multiple clinical studies at a global clinical research organization. Leads a TMF operations team to ensure regulatory adherence, document management quality, and audit readiness throughout the clinical trial lifecycle.

Responsibilities

  • 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

Requirements

  • 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
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