Clinical Trial Manager - Investigator Initiated Studies (Medical Device)

Location: Philadelphia, Pennsylvania; New York; New Jersey; Pittsburgh, Pennsylvania; Atlanta, Georgia; Washington, DC; Orlando, Florida; Fairfax, Virginia; or Boston, Massachusetts, United States

Salary: $90,000–$130,000 base salary annually, plus cash bonus.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive diagnostic and management solutions for coronary artery disease.

What you will do

• Oversee investigator-initiated clinical studies, including clinical sites, study documentation, vendors, and project deliverables.
• Develop trial timelines, enrollment projections, communication plans, monitoring plans, recruitment plans, risk mitigation plans, and contingency plans.
• Lead study start-up activities, including kick-off meetings, contract management, site onboarding, and training.
• Review informed consents, IRB approvals, research agreements, and other regulatory documents for compliance with study requirements and GCPs.
• Collaborate with investigators, site research coordinators, clinical research staff, field staff, core laboratories, data management teams, and vendors.
• Lead process improvement initiatives and support SOP development while tracking deliverables against timelines and budgets.

Requirements

• Bachelor’s degree in science or a health-related field.
• Minimum 5 years of relevant clinical research experience.
• Knowledge of ICH guidelines, US FDA requirements, and European clinical trial regulations.
• Excellent written and oral English communication skills required.
• Strong organizational skills, attention to detail, prioritization, and ability to manage multiple projects in a fast-paced environment.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Nice to have

• Experience managing investigator-initiated studies.
• Experience in cardiovascular medical device clinical research.

Culture & Benefits

• Work in a smaller, fast-paced team with an all-hands-on-deck approach.
• Collaborate across clinical research, onsite and field operations, investigators, research coordinators, and vendors.
• Support a company developing AI-driven tools for precision heart care.
• Employment includes a base salary and cash bonus opportunity.