Working Location: Nationwide Workplace Flexibility: Remote 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: <a href="https://www.olympusamerica.com/careers">https://www.olympusamerica.com/careers</a>.<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div>The Principal Clinical Project Manager is responsible for driving and overseeing the operational execution of large-scale, complex clinical trials and/or multiple concurrent strategic studies supporting clinical evidence generation objectives. This role manages study timelines, budgets, vendors, and operational deliverables while coordinating cross-functional study teams in a hub-and-spoke model to ensure eﬃcient study execution. Operating with a high degree of independence, the Principal CPM serves as the central point of coordination for the study core team, ensuring alignment across functional partners and maintaining accountability for study progress. This role is responsible for proactively identifying and managing risks, monitoring operational performance, and ensuring studies are delivered on time, within budget, and in compliance with applicable regulations and standards, including GCP, ICH, and FDA requirements. The Principal CPM also serves as the primary communicator of study status, providing clear and concise updates to internal stakeholders and leadership through regular reporting and presentations, and ensuring transparency around key milestones, risks, and overall study progress.</div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Duties</H2> </div><div><ul> <li>Lead operational execution of complex clinical trials from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestones.</li> <li>Serve as the central hub for the study core team, coordinating activities across Clinical Strategy, Data Management, Biometrics, Monitoring, Site Management, Data Systems, and Clinical Trial Associates.</li> <li>Ensure cross-functional alignment and accountability for study deliverables, tracking progress across functional areas and escalating risks, delays, or resource constraints to functional leadership when needed.</li> <li>Oversee end-to-end clinical trial operations, including site start-up, contract and site budget review processes, enrollment progress, monitoring strategy, vendor performance, and study closeout.</li> <li>Manage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study ﬁnancial performance.</li> <li>Coordinate the development of key study documents and operational plans, including protocols, CRFs, informed consent form (ICF), monitoring plan, data management plan, training plan, safety plan, etc.</li> <li>Coordinate safety oversight activities, supporting collaboration with Safety and Medical teams and operational coordination of DSMB, CEC, and other study governance committees.</li> <li>Ensure data integrity, regulatory compliance, and inspection readiness, partnering with Data Management, Biometrics, and Clinical Quality Assurance (CQA) to support data review, safety reporting, protocol deviation management, and audit preparedness.</li> <li>Manage CROs and external vendors, ensuring adherence to study plans, timelines, and performance expectations.</li> <li>Communicate study status, risks, and key milestones through regular reporting and presentations to internal stakeholders and senior leadership.</li> <li>Support investigator and site engagement, including investigator meetings, site training coordination, and enrollment oversight.</li> <li>Provide mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processes. </li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Qualifications</H2> </div><div>Required: <ul> <li>Bachelor’s degree in health sciences or related ﬁeld and 12+ years of clinical trial management experience or an equivalent combination of education and work experience.</li> <li>Financial acumen required; Clinical trial budget management experience required.</li> <li>Expertise with complex clinical research guidelines (i.e., 21CFR 312/812, ISO 14155, GDPR, GCP).</li> <li>Experience managing scope, budget and timeline.</li> <li>Has experience tackling challenging business problems that impact multiple teams.</li> <li>Able to communicate eﬀectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high levels of emotional intelligence.</li> <li>Proﬁcient computer skills (Electronic Data Capture, Microsoft Word, Excel, PowerPoint, MS Project, etc.) Strong organizational skills with high attention to detail and degree of accuracy.</li> <li>Skilled at collaborative and individual problem solving.</li> <li>Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials, which includes applicable ISO regulations for any trials conducted globally.</li> <li>Experience coordinating, prioritizing, setting timelines, and multi-tasking Professional demeanor and appearance.</li> <li>Ability to expertly create and deliver communication to all levels of leadership with the appropriate level of detail for the audience.</li> <li>Demonstrate the ability to resolve conﬂict, inﬂuence teams, and build relationships in meeting organizational objectives without formal authority</li> <li>Ability to work independently and manage multiple tasks in a fast-paced environment.</li> <li>Ability to work with and eﬀectively manage cross-functional teams.</li> <li>Ability to travel domestically up to 20-40% of the time. Some international travel up to 10%, may be expected.</li> </ul> Preferred: <ul> <li>Previous experience with medical device trials.</li> <li>Leadership – indirect or direct people leadership – ability to inﬂuence.</li> <li>MS/MPH degree in life sciences, or related ﬁeld.</li> <li>Participation on a product development (PDP) core team representing Clinical, strongly preferred. Has consistently delivered projects with broad business impact across multiple teams.</li> </ul></div></div></div>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: <ul> <li> Competitive salaries, annual bonus and 401(k)* with company match </li> <li> Comprehensive medical, dental, vision coverage effective on start date </li> <li> 24/7 Employee Assistance Program </li> <li> Free live and on-demand Wellbeing Programs </li> <li> Generous Paid Vacation and Sick Time </li> <li> Paid Parental Leave and Adoption Assistance* </li> <li> 12 Paid Holidays </li> <li> On-Site Child Daycare, Café, Fitness Center** </li> </ul> Connected Culture you can embrace: <ul> <li> Work-life integrated culture that supports an employee centric mindset </li> <li> Offers onsite, hybrid and field work environments </li> <li> Paid volunteering and charitable donation/match programs </li> <li> Employee Resource Groups </li> <li> Dedicated Training Resources and Learning & Development Programs </li> <li> Paid Educational Assistance </li> </ul> *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: <a href="https://www.olympusamerica.com/careers/benefits-perks">https://www.olympusamerica.com/careers/benefits-perks</a>. The anticipated base pay range for this full-time position in this location is $119,702.00 - $180,584.00 / 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 <a style="color:#0563c1;text-decoration:underline" href="https://www.olympusamerica.com/">www.olympusamerica.com</a>. 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 [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. <div> </div> Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs

Principal Clinical Project Manager (Center Valley, PA, US, 18034-0610) @ Olympus Corporation of the Americas

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