Senior Director, TMF Operations

4 days ago


Ahmedabad, Gujarat, India Emmes Full time

Job Summary

The Senior Director, TMF will lead the Trial Master File (TMF) Department at Emmes, a global Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation.

This role will oversee the delivery of high-quality, inspection-ready TMFs for projects and clients, ensuring compliance with industry best practices, regulatory requirements, and quality standards.

Key Responsibilities

  • Develop and implement a comprehensive TMF strategy, including metrics, process improvements, and adoption of new technology.
  • Lead a global team of employees and contractors, responsible for staff training, development, and performance management.
  • Support regulatory inspections and audits, providing subject matter expertise on TMF management and guidance to cross-functional teams and stakeholders.
  • Oversee eTMF system configuration, change control processes, and data migration.
  • Review and mitigate risks/deficiencies of TMF deliverables based on performance trend analyses and metrics.
  • Collaborate with Clinical Operations and department Directors/Leaders to implement new processes and review current processes for improvement.

Requirements

  • Bachelor's Degree and 15+ years of experience in Clinical Operations and TMF in CRO/pharmaceutical/biotechnology industry, or Master's Degree and 12+ years of experience.
  • At least 5 years of experience managing a global team, with past participation in regulatory inspections.
  • Experience in developing, implementing, and measuring success in departmental strategic plans.


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