Manager - TMF Operations in Chennai, India - Jobeax
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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