Manager, Tmf Operations

ICON Clinical Research, LP

Chennai, India
**
Trial master file management
Gcp and ich guideline compliance
Team leadership in regulated environment
** 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. **

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

** 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. **

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

Work Rights

Not specified

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