Clinical Operations, Compliance - Process & Training role
Key Responsibilities:
• Drive the development, optimization, alignment and implementation of clinical trial processes across Client Clinical Development
• Partner with equivalent Client functions for development, optimization and alignment of shared clinical trial processes
• Identify and Lead Process Improvement opportunities at Client
• 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 be able 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