Role Description

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.

Qualifications

• 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.
• Leadership – indirect or direct people leadership – ability to 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.

Requirements

• MS/MPH degree in life sciences, or related field (preferred).
• Participation on a product development (PDP) core team representing Clinical, strongly preferred.
• Previous experience with medical device trials.
• Direct people management experience and managing 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**.