Sr. Manager, Clinical Compliance

Job Description

This position will report into the ED, Head of Clinical Operations Compliance. In this role you will be a key member of the Kite Align team and work cross-functionally with the Clinical Development organization at Kite. Kite Align drives process and training alignment across the Kite Clinical Development organization and Gilead. You will partner closely with the Kite Research & Development Quality team and central process teams at Gilead.

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 (inclusive of Clinical Operations, Data Management and Clinical Logistics) 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
• 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
Basic Qualifications:
• Demonstrated ability to lead.
• BS or BA in a relevant scientific discipline and 8+ years of experience OR RN (2 or 3 year certificate) and 8+ years of experience.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
• Demonstrated understanding of end-to-end clinical trial processes.
Preferred Qualifications:
• Strong communication and influence skills and ability to create a clear sense of direction.
• Ability to examine functional issues from a broader organizational perspective.
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.