Insulet Corporation · 2 days ago
Clinical Device Data Specialist(Hybrid)
San Diego, CA
Full-time
Hybrid
Mid Level
$76K/yr - $115K/yr
3+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Clinical Device Data Specialist is responsible for ensuring the quality and integrity of device data collected during clinical studies, managing compliance with various regulations, and supporting the development of clinical study databases.
Health CareMedicalMedical Device
Responsibilities
Understand the device data collected as part of clinical studies (pre and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA requirements
Conduct regular reviews of device data to ensure quality and integrity and follow issues from identification through resolution
Support the development of clinical study databases and conduct data reviews including query generation/closure
Support device management including ordering, shipping, returns, tracking and forecasting as needed
Develop and/or review study-specific data management and database documentation, which may include but is not limited to: Data Management Plan (DMP), and Data Transfer Specifications (DTS) and training materials
Prepare data for scheduled snapshots/data locks
Ensure appropriate maintenance of study databases and device data including closure and archival upon study completion
Attend study-specific team meetings and produce requested metrics, which may include query information or data trends
Support set-up and management of the Device Data Portal for clinical studies
Ensure compliance with company policies and procedures as well as applicable regulatory requirements (e.g. federal/country and local)
Performs other duties as required
Qualification
Required
Bachelor's degree and/or an equivalent combination of education or experience
Minimum of 3+ years of clinical data and/or research experience
Preferred
Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule
Able to work in a high paced, changing environment and participate with other departments to achieve company goals
Excellent written and oral communications skills required
Proficiency in Microsoft Word and Excel required. Experience with database software and computerized statistical software is a plus
Working knowledge of Good Clinical Practices (GCP), ISO, FDA regulations including 21 CFR part 11, and current industry practices related to the conduct of clinical trials, developing databases and managing protected health information
Strong organizational skills and attention to details
Ability to work independently and manage multiple tasks in a fast-paced environment
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
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.
1001-5000 employees
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
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase