Clinical Study Manager (Medtech)

TL;DR

Clinical Study Manager (Medtech): Planning, designing, and executing clinical studies to assess the safety and effectiveness of medical products with an accent on project timelines, regulatory compliance, and vendor management. Focus on driving study-related documentation, managing budgets, and ensuring audit readiness across multidisciplinary teams.

Location: Remote (US Home Office), with willingness and ability to work on site as needed.

Salary: $123,000 - $170,000

Company

hirify.global is a global healthcare company focused on innovative therapies, designing and manufacturing novel products for challenging medical conditions.

What you will do

• Lead the planning, design, and execution of clinical studies to assess product safety and effectiveness.
• Develop and maintain project timelines from startup through completion, including regulatory submissions and database builds.
• Negotiate study budgets with sites, Core Labs, and external vendors.
• Manage the collection and tracking of regulatory documentation to ensure constant audit readiness.
• Coordinate activities across cross-functional teams, including Regulatory Affairs, Marketing, Legal, and R&D.
• Mentor and train staff on protocols and Good Clinical Practice (GCP) standards.

Requirements

• Bachelor's degree in Biological Sciences or a related field.
• 5+ years of relevant clinical trial experience (clinical research, nursing, or medical devices/pharmaceutical industry).
• Must be based in the United States.
• Strong knowledge of CFR, GCP/ICH requirements, and laws governing clinical studies.
• Proficiency with MS Project, EDC Systems, and study management systems.
• Fluency in English.

Culture & Benefits

• Collaborative teamwork environment with a focus on rewarding performance.
• Competitive compensation package including a benefits and equity program.
• Comprehensive medical, dental, vision, life, and disability insurance.
• 401(k) plan with employer match.
• Generous paid time off, including parental leave, sick time, and at least 15 days of accrued vacation.