Insulet Corporation · 15 hours ago
Clinical Project Manager (Hybrid)
Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Clinical Project Manager will manage and execute clinical studies, ensuring compliance with regulatory standards and leading the planning and execution of human factors studies.
Health CareMedicalMedical Device
Responsibilities
Coordinate and supervise study execution and contract management for usability and user preference studies, formative, and summative human factor studies
Review and approve protocols, study designs and reports for clinical and human factors studies
Work with Regulatory Affairs to manage US and international regulatory submissions for the conduct of clinical studies and the approval/clearance of new products. Manages all aspects of product launch for Product Support and Customer Care
Collaborate cross-functionally in preparation of documents for the Design History File and for regulatory filings
Proactively stay abreast of the latest regulations and GCP (Good Clinical Practice)
Support management of CRO and/or other outside clinical vendors
Co-manage study timelines and budgets
Drive clinical study communication to cross-functional teams
Support review of data analysis and interpretation of clinical information
Compile and summarize post market clinical information to support regulatory documentation
Support other tasks related to Insulet-sponsored clinical trials
Perform other duties as required
Qualification
Required
B.S. or B.A. (preferably in a Life Science field) or an equivalent combination of education and experience
5+ years of medical device or drug related clinical experience (with a minimum of 2 years direct project management experience preferred)
Endocrinology experience highly desired
Must have analytical skill, be detail oriented and have good interpersonal skills
Knowledge of agency guidelines and requirements
Excellent written and effective verbal communication skills
Proficient project management skills
Ability to prioritize multiple timelines and tasks
Ability to communicate at all levels of an organization
PC skill, word processing, spreadsheet, database
Internet search and utilization
Flexible and able to work in a fast-paced environment
Team player
Company
Insulet Corporation
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.
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase