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Associate Director Clinical Operations
2 months ago
Key Responsibilities:
- Drive the development, optimization, alignment and implementation of clinical trial processes across the company’s Clinical Development
- Partner with equivalent company functions for development, optimization and alignment of shared clinical trial processes
- Identify and Lead Process Improvement opportunities
- 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
