Director, Clinical Project Management

Job Description

This role reports directly to the Executive Director, Clinical Operations and collaborates closely with the leadership of Clinical Research to lead clinical studies project management 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 Operations 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

• In collaboration with the Global Clinical Operations leadership team, develop and implement a consistent and standardized approach to Clinical Project Management, leveraging integrated project plans to ensure clinical projects are executed within scope, on-time, on-budget and with high quality.  
• Manage 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.
• Ensure effective communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency.
• Align with Global Clinical Leads and Clinical Operations Management to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed.
• Identify opportunities for process improvement and develop/implement best practices to enhance the efficiency and effectiveness of clinical trial operations.
• In close collaboration with Clinical Quality Affairs, develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations.
• Implements a regional 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 oversee 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 Operations leadership team, takes ownership of the Clinical Operations mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Executive Director, Clinical Operations.
• Other duties as assigned.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field.
• Minimum of 10 years device/pharmaceutical industry experience in Clinical Operations with minimum of 5 years of direct experience in Clinical Project Management for pre and post-market trials required.
• Direct people management experience and managing teams. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
• Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• Strong communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
• Domestic and international travel up to 15%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
• Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings.

Preferred:

• MA/MS in life sciences or related field. PMP is desirable.
• Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP)
• Knowledge of budget and forecasting. Experience with clinical trial agreement negotiation preferred.