Senior Manager, Clinical Affairs Project Management (Hybrid - Acton,MA/San Siego, CA)

Job Title: Senior Manager, Clinical Affairs Project Management

Department: QA Clinical

Manager/Supervisor: Senior Director, Clinical Affairs

Position Overview

The Senior Manager of Clinical Affairs Project Management is responsible for leading and executing complex clinical projects and initiatives across global markets. This role ensures strategic alignment, operational excellence, and compliance with regulatory standards throughout all phases of clinical study planning and execution. The position requires strong leadership, cross-functional collaboration, and the ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead and oversee clinical project management activities for multiple studies, ensuring adherence to timelines, budgets, and quality standards.
• Manage and mentor Clinical Project Managers and support staff, fostering a culture of accountability and continuous improvement.
• Champion process improvement initiatives to optimize workflows, establish best practices, and ensure consistent, efficient project management across all clinical studies.
• Develop and implement project plans, risk mitigation strategies, and contingency plans.
• Serve as the primary liaison between Clinical Affairs and cross-functional teams (Medical Affairs, R&D, Regulatory, Quality, Legal, and Operations).
• Oversee vendor selection, contract negotiations, and performance management for CROs and other external partners.
• Ensure compliance with applicable regulatory requirements, including GCP, ISO 14155, and FDA guidelines.
• Monitor study progress, resolve complex issues, and escalate as needed to senior leadership.
• Contribute to protocol development, IDE submissions, and interactions with regulatory authorities.
• Prepare and present project status reports and key performance metrics to stakeholders.
• Performs other duties as required.
  
  

Education And Experience

• Bachelor’s degree in Life Sciences, Health Sciences, or related field (advanced degree preferred).
• Minimum 8 years of experience in clinical research or project management within the medical device or pharmaceutical industry.
• Proven experience managing global clinical trials and cross-functional teams.
• Strong knowledge of regulatory requirements and clinical trial processes.
• Diabetes experience highly desirable.
  
  

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).  

Additional Information

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $137,400.00 - $206,100.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.
  
  

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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