Executive Director, Global Clinical Operations

Working Location: MASSACHUSETTS, WESTBOROUGH; PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

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Job Description

The Executive Director of Global Clinical Operations reports directly to the Global Head of Clinical Research and collaborates closely with the MSA leadership team to provide strategic leadership and direction for the clinical operations team including the oversight of all aspects of clinical studies in support of clinical evidence generation strategies across global business unit portfolios.

The individual is a critical member of Clinical Affairs leadership team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the global business units, and within the broader Olympus organization, as appropriate. 

Job Duties

• Provide strategic leadership and direction to the Clinical Operations team including project management, clinical monitoring, site management and clinical trial logistics.
• Develop and implement processes and procedures to optimize project management team using integrated project plans to ensure clinical projects are executed within scope, on-time, on-budget and with high quality.  
• Strategically develop competencies within the Clinical Project Management 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. 
• Establish and manage processes for regular communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency.
• Align with Global Clinical Leads to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed.
• 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 Affairs, 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. 
• Leads strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans.
• 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. 
• As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to t