Title : Associate Director - Clinical Operations, Compliance - Process & Training role
Location : 100% Remote
Duration : 6 months contract
Pay Range : $70.00 - $85.00 USD hourly on W2 Key Responsibilities:
•Drive the development, optimization, alignment and implementation of clinical trial processes across Kite Clinical Development
•Partner with equivalent Gilead functions for development, optimization and alignment of shared clinical trial processes
•Identify and Lead Process Improvement opportunities at Kite
•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