Clinical Operations Director

3 days ago


San Francisco, California, United States Integrated Resources Full time
Clinical Operations and Compliance Role

Integrated Resources is seeking a highly skilled 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 our Client Clinical Development organization.

Key Responsibilities:
  • Develop and maintain clinical trial processes, ensuring alignment with regulatory requirements and industry best practices.
  • Partner with cross-functional teams to develop and optimize shared clinical trial processes.
  • Identify and lead process improvement initiatives to enhance efficiency and compliance.
  • 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 required.
  • 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 accordingly.
  • Lead efforts to increase compliance awareness and a culture of compliance within the organization.
Requirements:
  • Deep knowledge of international GCP regulatory requirements.
  • Understanding of end-to-end clinical trial processes.
  • Organizational awareness and ability to lead cross-functional initiatives.
  • Excellent communication and negotiation skills.
  • Critical and creative thinking to resolve complex problems.
  • Ability to prioritize and adjust workload to meet evolving department and regulatory needs.


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