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ICON Clinical Research is seeking a Manager for TMF Operations in Chennai, India. The successful candidate will oversee the management and compliance of the Trial Master File (TMF) for clinical research studies, ensuring adherence to regulatory standards while leading a team focused on quality and documentation.
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Job Summary
The role involves leading a team to ensure Trial Master File documentation is accurate, complete, and compliant with regulatory requirements throughout the clinical trial lifecycle.
ICON fosters an inclusive environment that rewards high performance and nurtures talent through competitive benefits including health insurance and retirement planning.
Candidates must possess extensive experience in TMF management or clinical operations within the pharmaceutical industry to support successful execution of clinical trials.
Matching Summary
Match Score: 75
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ICON Clinical Research is seeking a Manager for TMF Operations in Chennai, India. The successful candidate will oversee the management and compliance of the Trial Master File (TMF) for clinical research studies, ensuring adherence to regulatory standards while leading a team focused on quality and documentation.
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Skills & Requirements
Must-have
Trial Master File management
GCP and ICH guideline compliance
Team leadership in regulated environment
Cross-functional collaboration skills
Electronic TMF system proficiency
Nice-to-have
Advanced degree in clinical operations
Document management certification
Continuous process enhancement mindset
Culture of quality and compliance
Strategic policy development experience
Key Requirements
Bachelor's degree in life sciences or related field
Extensive TMF management experience required
Proven leadership skills managing teams
Strong understanding of global regulatory requirements