Clinical Operations, Compliances

Description:

Clinical Operations, Compliance – Process & Training role

Key Responsibilities:

· Drive the development, optimization, alignment and implementation of clinical trial processes across Company Clinical Development

· Partner with equivalent company functions for development, optimization and alignment of shared clinical trial processes

· Identify and Lead Process Improvement opportunities at Company

· 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