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: https://www.olympusamerica.com/careers.
This role 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.
In addition, this role operates in a coach-plus-player model, maintaining direct accountability for assigned studies (as applicable) while providing people leadership, guidance, and development support to Clinical Project Management staff.
Operating with a high degree of independence, this role 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.
In close collaboration with the Director, Clinical Project Management and 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.
This role could also serve 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.
- Lead operational execution of complex clinical trials from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestones.
- 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.
- 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.
- 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.
- Manage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study financial performance.
- 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.
- Coordinate safety oversight activities, supporting collaboration with Safety and Medical teams and operational coordination of DSMB, CEC, and other study governance committees.
- 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.
- Manage CROs and external vendors, ensuring adherence to study plans, timelines, and performance expectations.
- Communicate study status, risks, and key milestones through regular reporting and presentations to internal stakeholders and senior leadership.
- Support investigator and site engagement, including investigator meetings, site training coordination, and enrollment oversight.
- Provide direct oversight, mentorship, and performance feedback to assigned Clinical Project Management staff while maintaining hands-on responsibility for study execution.
- Support onboarding, training, workload balancing, and professional development of CPM team members.
- Provide mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processes.
Required:
- Bachelor’s degree in health sciences or related field and a minimum of 12 years of clinical trial management experience or an equivalent combination of education and work experience.
- Experience managing scope, budget and timeline.
- Minimum of 3+ years of experience managing teams, direct reports, or leading complex programs and the ability to coach, develop, and influence.
- Has consistently delivered projects with broad business impact across multiple teams.
- Has experience tackling challenging business problems that impact multiple teams.
- Financial acumen required; Clinical trial budget management experience required.
- Expertise with complex clinical research guidelines (i.e., 21CFR 312/812, ISO 14155, GDPR, GCP).
- Able to communicate effectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high levels of emotional intelligence.
- 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
- Skilled at collaborative and individual problem solving.
- 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.
- Experience coordinating, prioritizing, setting timelines, and multi-tasking.
- Professional demeanor and appearance.
- Ability to expertly create and deliver communication to all levels of leadership with the appropriate level of detail for the audience.
- Demonstrate the ability to resolve conflict, influence teams, and build relationships in meeting organizational objectives without formal authority.
- Ability to work independently and manage multiple tasks in a fast-paced environment.
- Ability to work with and effectively manage cross-functional teams.
- Ability to travel domestically up to 40% of the time. Some international travel up to 10% may be expected.
Preferred:
- Previous experience with medical device trials.Direct people management or team leadership experience (formal or informal).
- MS/MPH degree in life sciences, or related field.
- Participation on a product development (PDP) core team representing Clinical, strongly preferred.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
WORK ENVIRONMENT
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Olympus Corporation of the Americas is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended to summarize the primary responsibilities and qualifications for this position. The job description is not intended as inclusive of all duties an induvial in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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:
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
**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 is $119,702.00 - $167,584.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
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 [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.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs
