Associate Director - Varite, Inc
Santa Monica, CA 90404
About the Job
Pay rate range: $90-100/hr.
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 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.
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 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.
Source : Varite, Inc
