Clinical Systems Director

2 weeks ago


San Diego, California, United States Fate Therapeutics Full time
Job Summary

Fate Therapeutics is seeking a highly skilled Clinical Systems Director to lead the operational leadership and oversight of the clinical systems function within Clinical Operations.

This key contributor will be responsible for ensuring the consistent use and application of technology and standards, ensuring complete and accurate documentation and management of study data across all programs.

The successful candidate will partner internally and externally to implement and maintain high-quality, efficiently designed clinical systems, including the eTMF and CTMS.

  • Lead the Clinical Systems function, acting as a subject matter expert (SME) and system administrator for Clinical Operations systems.
  • Accountable for partnering internally and externally to implement and maintain high-quality, efficiently designed clinical systems.
  • Own all aspects of Veeva eTMF/CTMS and applicable analytics tools, including system administration, training, SOPs, storage, etc.
  • Ensure that the eTMF/CTMS are always inspection ready; partner with Quality to ensure Part 11 compliance for all relevant supported systems.
  • Lead systems vendor selection and perform ongoing service provider management and oversight of clinical system vendors.
  • Monitor key performance indicators (KPIs) and conduct analysis to identify root causes for issues and recommend process improvements.

The ideal candidate will have a BS/BA degree in a related discipline and 7+ years of related clinical operations and clinical systems experience in biotech/pharma.

Experience in clinical trial planning and execution, computer validation knowledge, and mastery of global regulatory requirements and guidelines for managing eTMF are strongly preferred.

The successful candidate will be able to see the interrelationship of systems and procedures within a project and understand their interdependencies to the larger organization and drive strategic changes needed by the business.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases.

We value diversity and are committed to creating an inclusive environment for all employees.



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