Director Clinical Operations Compliance Process Training role
Director Clinical Operations Compliance Process Training role
Posted on :
17-09-2024
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Posted on :
17-09-2024
Job Description
Director (Clinical Operations Compliance Process & Training role)
Job Location: Santa Monica California
This is 100% remote
Job Duration: 6 months
Payrate: $75$80/hr 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 endtoend clinical trial processes
- Organizational Awareness
- Independently lead and manage crossfunctional 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
Employment Type
Full Time
Key Skills
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