Clinical Operations Director

4 weeks ago


Santa Monica, California, United States Mindlance Full time
Clinical Operations, Compliance - Process & Training Role

Mindlance is seeking a highly skilled Clinical Operations Director to join our team. As a key member of our Clinical Development department, you will be responsible for driving the development, optimization, and implementation of clinical trial processes across Kite Clinical Development.

Key Responsibilities:
  • Develop and maintain clinical trial processes, ensuring compliance with international GCP regulatory requirements.
  • Partner with cross-functional teams to develop, optimize, and align shared clinical trial processes.
  • Identify and lead process improvement opportunities to enhance efficiency and quality.
  • Establish and maintain training curricula for Clinical Operations and support other Clinical Development functions as needed.
  • Develop onboarding plans for Clinical Operations and support transition planning within the department.
  • Proactively monitor compliance with Clinical Operations procedural documents and training requirements.
  • Develop and report process and training compliance metrics.
  • Support internal audits and regulatory authority inspections as needed.
  • Maintain awareness of industry and regulatory changes to ensure Clinical Development processes are updated as necessary.
  • Lead and support efforts to increase compliance awareness and a culture of compliance.
Knowledge & Skills:
  • In-depth knowledge of international GCP regulatory requirements.
  • Deep understanding of end-to-end clinical trial processes.
  • Organizational awareness and ability to lead cross-functional initiatives.
  • Excellent communication skills and ability to negotiate sensitive issues.
  • Critical and creative thinking to resolve complex problems.
  • Ability to prioritize and adjust workload to meet evolving department and regulatory needs.
  • Lead by example to champion quality and compliance.
EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.



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