Associate Director

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