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Clinical Operations Compliance Director

2 mesi fa

San Remo, Liguria, Italia Integrated Resources, Inc ( IRI ) A tempo pieno
Associate Director Clinical Operations Compliance

Integrated Resources, Inc (IRI) is seeking a highly skilled Associate Director Clinical Operations Compliance to join our team.

Key Responsibilities:
  • Develop and optimize clinical trial processes across Client Clinical Development
  • Partner with Client functions to develop and optimize shared clinical trial processes
  • Identify and lead process improvement opportunities at Client
  • Establish and maintain training curricula for Clinical Operations and support other Clinical Development functions
  • Develop onboarding plans for Clinical Operations and support transition planning
  • 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
  • Maintain awareness of industry and regulatory changes to ensure Clinical Development processes are updated
  • Lead efforts to increase compliance awareness and a culture of compliance

Requirements:

  • 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 and negotiation skills
  • Critical and creative thinking to resolve complex problems
  • Ability to prioritize and adjust workload to meet evolving department and regulatory needs