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Director of Clinical Operations and Compliance
2 months ago
**Job Summary:**
We are seeking an experienced Associate Director to lead our Clinical Operations and Compliance team at Intelliswift Software. As a key member of our organization, you will be responsible for driving the development, optimization, and implementation of clinical trial processes across our Client Clinical Development team.
Key Responsibilities:
- Develop and Optimize Clinical Trial Processes: Collaborate with cross-functional teams to design, implement, and maintain clinical trial processes that meet regulatory requirements and industry standards.
- Partner with Gilead Functions: Work closely with equivalent Gilead functions to develop, optimize, and align shared clinical trial processes, ensuring seamless integration and compliance.
- Identify and Lead Process Improvement Opportunities: Proactively identify areas for process improvement and lead initiatives to enhance efficiency, reduce costs, and improve quality.
- Establish and Maintain Training Curricula: Develop and implement training programs for Clinical Operations and support other Clinical Development functions as needed, ensuring compliance with regulatory requirements.
- Develop Onboarding Plans: Create comprehensive onboarding plans for Clinical Operations to ensure a smooth transition for new team members.
- Support Transition Planning: Collaborate with stakeholders to develop and implement transition plans for Clinical Operations, ensuring minimal disruption to business operations.
- Monitor Compliance: Proactively monitor compliance with Clinical Operations procedural documents and training requirements, identifying and addressing any gaps or issues.
- Develop and Report Compliance Metrics: Establish and track key performance indicators (KPIs) to measure compliance and process efficiency, providing regular reports to stakeholders.
- Support Audits and Inspections: Collaborate with internal and external auditors to ensure compliance with regulatory requirements and industry standards, supporting audit and inspection responses as needed.
- Maintain Industry Awareness: Stay up-to-date with changes in the industry and regulatory environment, ensuring Clinical Development processes are updated accordingly.
- Lead Compliance Awareness Efforts: Champion a culture of compliance within the organization, promoting awareness and understanding of regulatory requirements and industry standards.
Requirements:
- International GCP Regulatory Requirements: In-depth knowledge of international GCP regulatory requirements and industry standards.
- End-to-End Clinical Trial Processes: Deep understanding of end-to-end clinical trial processes, including design, implementation, and maintenance.
- Organizational Awareness: Strong understanding of organizational dynamics and the ability to navigate complex relationships.
- Leadership and Management: Proven ability to lead and manage cross-functional initiatives, prioritizing tasks and adjusting workload as needed.
- Communication and Negotiation: Excellent communication and negotiation skills, with the ability to provide clear and concise instructions and negotiate sensitive issues objectively.
- Critical Thinking and Problem-Solving: Critical and creative thinking skills to resolve complex problems and develop innovative solutions.
- Quality and Compliance: Strong commitment to quality and compliance, with the ability to lead by example and champion a culture of compliance.
