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.

Hybrid:
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid

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.