Senior Director, Global Head of Clinical Operations

Job Description

Job Duties

• Provide strategic leadership and direction to the Global Clinical Operations team including project management, clinical monitoring, site management, data management and statistics.
• Oversee end-to-end operational delivery of global clinical trials, including timelines, quality, budget adherence, enrollment performance, and risk mitigation.
• Oversee investigator initiated and collaborative research programs, ensuring that projects are completed according to the contracted timelines and project deliverables are received.
• Leads strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans.
• Align with Global Clinical Leads to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed.
• Establish and manage processes for regular communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency.
• Ensure robust study oversight plans, monitoring strategies, data management strategies and statistical methods are implemented consistently across programs.
• Develop and implement processes and procedures to optimize clinical trial operations to ensure clinical projects are executed within scope, on-time, on-budget and with high quality.  
• Strategically develop competencies within the Global Clinical Operations team using proactive identification of resourcing needs, screening and hiring of candidates, training on departmental responsibilities and expectations, providing mentorship and guidance, fostering a culture of continuous learning and professional development.
• Identify opportunities for process improvement and implement best practices to enhance the efficiency and effectiveness of clinical trial operations.
• In close collaboration with Clinical Quality Assurance, supports the development and maintenance of Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations.
• Partner with Clinical Quality Assurance to prepare for and support regulatory agency inspections and sponsor audits.
• Develops and implement an outsourcing strategy as required to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s).
• Establish and oversees activities to ensure regulatory compliance across all project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools.
• Ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.