Associate Director Clinical Operations

4 days ago


Santa Monica, California, United States The Fountain Group Full time

Key Responsibilities:

  • Drive the development, optimization, alignment, and implementation of clinical trial processes across The Fountain Group's Clinical Development department.
  • Partner with equivalent company functions for the development, optimization, and alignment of shared clinical trial processes.
  • Identify and lead process improvement opportunities to enhance operational efficiency and compliance.
  • Establish and maintain comprehensive training curricula for Clinical Operations and support other Clinical Development functions as needed.
  • Develop onboarding plans for Clinical Operations to ensure a smooth transition for new team members.
  • Support transition planning within Clinical Operations to ensure continuity and minimize disruptions.
  • Proactively monitor compliance with Clinical Operations procedural documents and training requirements to maintain a culture of excellence.
  • Develop and report process and training compliance metrics to inform strategic decision-making.
  • Support and participate in internal audits and regulatory authority inspections to ensure compliance and identify areas for improvement.
  • Support the development of audit/inspection response strategies and CAPA implementation to address any findings.
  • 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 foster a culture of compliance throughout the organization.

Knowledge & Skills:

  • Deep understanding of international GCP regulatory requirements and their application in clinical trials.
  • Expertise in end-to-end clinical trial processes, including design, execution, and monitoring.
  • Strong organizational awareness and ability to lead cross-functional initiatives.
  • Excellent communication skills, with the ability to provide clear and concise instructions and guidance.
  • Negotiation skills to resolve sensitive issues in an objective and professional manner.
  • Critical and creative thinking to resolve complex problems and identify innovative solutions.
  • Ability to prioritize and adjust workload to meet evolving department and regulatory needs.
  • Leadership skills to champion quality and compliance, and lead by example to inspire a culture of excellence.


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