Manager - TMF Operations in 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