Working Location: Nationwide
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. 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. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: https://www.olympusamerica.com/careers
Job Description
This role 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 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 implements 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 the Global Head of Clinical Affairs. Other duties as assigned.
Job Qualifications
Required:
Preferred:
Why Join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on:
Connected Culture you can embrace:
*US Only **Center Valley, PA and Westborough, MA
Are you ready to be a part of our team? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $162,565.00 - $243,847.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.
We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).