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Clinical Operations Director

2 months ago

Santa Monica, California, United States Intelliswift Software Full time

Job Title Associate Director (Clinical Operations, Compliance – Process & Training role)

Location : Santa Monica, CA

Duration : 6 months

Key Responsibilities:

  • Drive the development, optimization, alignment, and implementation of clinical trial processes across Client Clinical Development
  • Partner with equivalent Gilead functions for development, optimization, and alignment of shared clinical trial processes
  • Identify and lead process improvement opportunities at Client's location
  • Establish and maintain the training curricula for Clinical Operations and support other Clinical Development functions, as needed
  • Develop onboarding plans for Clinical Operations
  • Support transition planning within Clinical Operations as needed
  • Proactively monitor compliance with Clinical Operations procedural documents and training requirements
  • Develop and report process and training compliance metrics
  • Support and participate in internal audits and regulatory authority inspections, as needed
  • Support audit/inspection response development and CAPA implementation, as needed
  • Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) 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
  • Independently lead and manage cross-functional initiatives
  • Excellent communication skills, provide clear and concise instructions
  • Negotiate sensitive issues in an objective manner
  • 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