Senior Manager, Global Clinical Affairs Data (Medical Device)

Location: Hybrid, with on-site work required at an hirify.global office in Acton, Massachusetts, United States

Annual base salary for U.S.-based positions: $147,000–$220,500, plus potential incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable subcutaneous drug-delivery technologies.

What you will do

• Lead clinical data management activities across multiple pre- and post-market studies.
• Create and review study-specific Case Report Forms and develop reusable CRF libraries.
• Design, configure, validate, and coordinate User Acceptance Testing for Electronic Data Capture databases.
• Prepare data management plans, CRF guidelines, annotated CRFs, edit-check specifications, and UAT plans.
• Conduct data review, generate and close queries, prepare database snapshots and locks, and manage database closure and archival.
• Develop study tracking and data-quality metrics, improve clinical processes, and support investigator and coordinator training.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• At least 6 years of clinical data management and/or systems experience.
• Experience with multiple Electronic Data Capture systems and strong computer skills.
• Working knowledge of Good Clinical Practices, FDA regulations, applicable ISO requirements, HIPAA, GDPR, and 21 CFR Part 11.
• Strong organizational, communication, prioritization, and attention-to-detail skills, with the ability to manage multiple priorities independently.
• Ability to work on-site as part of a hybrid arrangement in Acton, Massachusetts.

Culture & Benefits

• Hybrid working arrangement with up to 5% travel.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Performance-driven environment focused on improving outcomes for people with diabetes and other conditions.