Associate Director - Clinical Operations

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Job description

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

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