Note: The job is a remote job and is open to candidates in USA. Olympus Corporation is a global medical technology company focused on improving patient outcomes through innovative solutions. They are seeking a Principal Clinical Project Manager to oversee the operational execution of complex clinical trials, ensuring timely delivery, budget management, and regulatory compliance while coordinating cross-functional teams.
Responsibilities
- 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 mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processes
Skills
- 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
- Financial acumen required; Clinical trial budget management experience required
- Expertise with complex clinical research guidelines (i.e., 21CFR 312/812, ISO 14155, GDPR, GCP)
- Experience managing scope, budget and timeline
- Has experience tackling challenging business problems that impact multiple teams
- 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 20-40% of the time. Some international travel up to 10%, may be expected
- Previous experience with medical device trials
- Leadership – indirect or direct people leadership – ability to influence
- MS/MPH degree in life sciences, or related field
- Participation on a product development (PDP) core team representing Clinical, strongly preferred. Has consistently delivered projects with broad business impact across multiple teams
Benefits
- 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
- 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
- US Only
- Center Valley, PA and Westborough, MA
Company Overview
Olympus is passionate about creating customer-driven solutions for the medical industry. It was founded in 1919, and is headquartered in Shinjuku, Yamanashi, JPN, with a workforce of 10001+ employees. Its website is https://heylink.me/yokubet.id/.