Clinical Operations Director

3 days ago


Santa Monica, California, United States Mindlance Full time
Clinical Operations and Compliance Role

Mindlance is seeking an experienced Clinical Operations and Compliance professional to join our team. As an Associate Director, you will play a key role in driving the development, optimization, and implementation of clinical trial processes across Kite Clinical Development.

Key Responsibilities:
  • Develop and optimize clinical trial processes to ensure compliance with regulatory requirements and industry standards.
  • Partner with cross-functional teams to develop and implement process improvements and training programs.
  • Identify and lead process improvement opportunities to enhance clinical trial 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 as needed.
  • 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 changes within the industry and regulatory environment to ensure Clinical Development processes are updated as necessary.
  • Lead and support efforts to increase compliance awareness and a culture of compliance.
Knowledge and Skills:
  • Deep understanding of international GCP regulatory requirements.
  • 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.
EEO Statement:

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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