Senior Clinical Trial Associate (Medical Device Clinical Trials)

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

Salary: $76,400–$114,575 annual base salary for U.S.-based positions; incentive compensation may also apply.

Company

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

What you will do

• Provide end-to-end operational support for clinical trials from feasibility and study startup through site initiation, maintenance, and closeout.
• Track study timelines, milestones, enrollment metrics, risks, issues, and operational deliverables.
• Coordinate clinical sites, CROs, vendors, Clinical Project Management, Regulatory, Quality, Finance, and other stakeholders.
• Support the development, review, execution, and controlled distribution of protocols, monitoring plans, informed consent forms, and study manuals.
• Own eTMF maintenance and quality, perform quality checks, resolve discrepancies, and support reconciliation and inspection readiness.
• Support regulatory submissions, trial registrations, budgets, purchase orders, invoices, forecasting, vendor oversight, audits, and process improvement.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related discipline, or an equivalent combination of education and experience.
• At least 4 years of progressively responsible clinical research or clinical operations experience for the Senior CRA level, preferably in medical devices, pharmaceuticals, or biotechnology.
• Hands-on experience supporting regulated clinical trials and working with CROs, clinical vendors, and global clinical sites.
• Strong knowledge of FDA regulations, ISO 14155, ICH GCP, company SOPs, and clinical trial procedures.
• Experience with eTMF, CTMS, document control platforms, Microsoft Word, Excel, databases, and other clinical systems.
• Ability to work independently, manage multiple studies and deadlines, identify issues, and maintain high-quality inspection-ready documentation.

Culture & Benefits

• Hybrid working arrangement with required office attendance.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Opportunity to mentor junior clinical team members and contribute to clinical best practices and operational excellence.