Insulet Corporation · 3 months ago
Senior Manager, Global Clinical Affairs Data (Hybrid)
US - Massachusetts (Acton - Office)
Full-time
Hybrid
Senior Level, Lead/Staff
$143K/yr - $215K/yr
10+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Senior Manager, Global Clinical Affairs Data is responsible for managing data for global studies, including data collection, processing, and reporting to regulatory agencies.
Health CareMedicalMedical Device
Responsibilities
Identify and manage sources of data, identify efficient data collection pathways, manage data processing, identify and manage data flows, collaborate cross-functionally to ensure data privacy, manage data integrity by implementing quality control checks to ensure accuracy, troubleshoot data issues, and data distribution for all global studies
Performing User Acceptance Testing of clinical databases
Liaise with the biostatistician to ensure alignment on data collection and analysis
Collaborate on study close-out activities and manage the database lock
Ensure all adverse event documentation is sufficiently detailed to facilitate adjudication
Collaborate cross-functionally to obtain all study data related to an adverse event
Manage communication of all adverse event reporting to the Medical Monitor or Data Safety Monitoring Board when applicable
Manage the finalization of the report shell in collaboration with Medical Affairs
Summarize the data analysis and collaborate to write a formal report for regulatory agencies
Manage the distribution of data to clinical sites after the completion of a study
Manage data retention for each study according to internal processes and regulations
Define and manage internal data management processes for all global studies
Develop data management plans for all global studies
Performs other duties as required
Qualification
Required
Bachelor's degree and/or an equivalent combination of education or experience
Minimum of 10 years of relevant experience in the field
Must have analytical skills, be detail-oriented, and have good interpersonal skills
Knowledge of agency guidelines and requirements
Excellent written and effective verbal communication skills
Ability to communicate cross-functionally across the organization
PC skills; word processing, spreadsheet, database, Internet search and utilization
Flexible and able to work in a fast-paced environment
Team player
Ability to organize and judge priorities
Excellent ability to generate and maintain accurate records
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