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Clinical Operations Director
2 months ago
We are seeking a highly skilled Clinical Operations Director to join our team at ATR International. As a key member of our Clinical Development department, you will be responsible for driving the development, optimization, and implementation of clinical trial processes across our organization.
Key Responsibilities- Process Development and Optimization: Develop, optimize, and align clinical trial processes across Kite Clinical Development, ensuring compliance with regulatory requirements and industry best practices.
- Collaboration and Partnership: Partner with equivalent client functions to develop, optimize, and align shared clinical trial processes, fostering a culture of collaboration and cooperation.
- Process Improvement: Identify and lead process improvement opportunities at Kite, driving continuous improvement and enhancing operational efficiency.
- Training and Development: Establish and maintain training curricula for Clinical Operations and support other Clinical Development functions as needed, ensuring that all team members have the necessary skills and knowledge to perform their roles effectively.
- Onboarding and Transition Planning: Develop onboarding plans for Clinical Operations and support transition planning within the department as needed, ensuring a smooth handover of responsibilities.
- Compliance and Risk Management: Proactively monitor compliance with Clinical Operations procedural documents and training requirements, identifying and mitigating risks to ensure regulatory compliance.
- Metrics and Reporting: Develop and report process and training compliance metrics, providing insights and recommendations for improvement.
- Audit and Inspection Support: Support and participate in internal audits and regulatory authority inspections as needed, ensuring that our processes and procedures are compliant with regulatory requirements.
- Industry Awareness and Compliance: Maintain awareness of changes within the industry and regulatory environment, ensuring that our clinical development processes are updated as necessary to reflect new requirements and best practices.
- Compliance Culture: Lead and support efforts to increase compliance awareness and foster a culture of compliance within the organization.
- Regulatory Knowledge: In-depth knowledge of international GCP regulatory requirements and a deep understanding of end-to-end clinical trial processes.
- Leadership and Management: Ability to independently lead and manage cross-functional initiatives, with excellent communication skills and the ability to provide clear and concise instructions.
- Critical Thinking and Problem-Solving: Critical and creative thinking to resolve complex problems, with the ability to prioritize and adjust workload to meet evolving department and regulatory needs.
- Quality and Compliance: Lead by example to champion quality and compliance, with a strong commitment to ensuring that our processes and procedures are compliant with regulatory requirements.
