Director of Clinical Operations and Compliance

7 giorni fa


San Remo, Liguria, Italia Integrated Resources, Inc ( IRI ) A tempo pieno
Job Summary

We are seeking a highly skilled and experienced Associate Director of Clinical Operations and Compliance to join our team at Integrated Resources, Inc. (IRI). This is a key leadership role that will be responsible for driving the development, optimization, and implementation of clinical trial processes across our organization.

Key Responsibilities
  • Process Development and Optimization: Develop, optimize, and align clinical trial processes across our organization to ensure compliance with regulatory requirements and industry standards.
  • Process Improvement: Identify and lead process improvement opportunities to enhance efficiency, quality, and compliance.
  • Training and Development: Establish and maintain training curricula for clinical operations and support other clinical development functions as needed.
  • Compliance and Quality Assurance: Proactively monitor compliance with clinical operations procedural documents and training requirements, and develop and report process and training compliance metrics.
  • Audit and Inspection Support: Support internal audits and regulatory authority inspections, and participate in audit/inspection response development and CAPA implementation as needed.
  • Industry and Regulatory Awareness: Maintain awareness of changes within the industry and regulatory environment to ensure clinical development processes are updated as necessary.
  • Compliance Culture: Lead and support efforts to increase compliance awareness and a culture of compliance within our organization.
Requirements
  • International GCP Regulatory Requirements: In-depth knowledge of international GCP regulatory requirements.
  • End-to-End Clinical Trial Processes: Deep understanding of end-to-end clinical trial processes.
  • Organizational Awareness: Strong organizational awareness and ability to lead and manage cross-functional initiatives.
  • Communication and Negotiation Skills: Excellent communication and negotiation skills, with the ability to provide clear and concise instructions and negotiate sensitive issues in an objective manner.
  • Critical and Creative Thinking: Critical and creative thinking to resolve complex problems and prioritize workload to meet evolving department and regulatory needs.
  • Quality and Compliance Leadership: Ability to lead by example and champion quality and compliance within our organization.


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