Senior Manager, Clinical Operations (Medical Devices)

TL;DR

Senior Manager, Clinical Operations (Medical Devices): Leading the design and execution of clinical trials for respiratory therapy devices with an accent on regulatory compliance and operational excellence. Focus on managing CROs, developing study protocols, and overseeing a growing team to ensure trial success.

Location: Hybrid - Must be based in or be able to commute to the Minnetonka, MN office (3-4 days per week)

Salary: $150,000 – $175,000 per year

Company

hirify.global develops innovative medical devices and software to diagnose and treat serious cardiopulmonary and respiratory conditions worldwide.

What you will do

• Lead clinical trial operational execution, including site identification, subject recruitment, and monitoring.
• Develop clinical study protocols and supporting documentation for new clinical projects.
• Manage internal teams, Contract Research Organizations (CROs), and third-party vendors.
• Oversee study budgets, timelines, and resource allocation across clinical programs.
• Ensure strict compliance with ICH-GCP, ISO, CFR, and European MDR regulatory standards.
• Provide leadership and professional development for direct reports through performance reviews and goal setting.

Requirements

• Bachelor's Degree in a scientific field (advanced degree preferred).
• 5+ years of leadership in clinical or scientific research within the medical device industry.
• 3-4+ years of direct people management experience.
• Proficiency with CTMS, EDC, and electronic Trial Master Files (eTMF) systems.
• Experience with Premarket Approval (PMA) devices.
• Deep knowledge of global regulations including ICH-GCP and European MDR.

Culture & Benefits

• Hybrid work model offering a balance of in-office collaboration and remote flexibility.
• Eligible for an annual performance bonus.
• Comprehensive benefits package.
• Culture focused on innovation, self-motivation, and an entrepreneurial spirit.