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Form of workJob Description
Job Title: Associate Director (Clinical Operations)
Job Location: Santa Monica, CA (100% Remote role)
Job Duration: 6 Months (Possible Extension)
Pay Rate: $120/hour on W2.
Job Description:
Knowledge & Skills:
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Job Location: Santa Monica, CA (100% Remote role)
Job Duration: 6 Months (Possible Extension)
Pay Rate: $120/hour on W2.
Job Description:
- Drive the development, optimization, alignment and implementation of clinical trial processes across Client Clinical Development.
- Partner with equivalent Client functions for development, optimization and alignment of shared clinical trial processes.
- Identify and Lead Process Improvement opportunities at Client.
- 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.
#hczr1
