Cardio Clinical Trial Manager — Fast-Paced, Impactful

Heartflow; Pittsburgh (Allegheny County); On-site; USD 95,000 - 130,000; Full time

Job summary

Heartflow, a medical technology company based in Pittsburgh, PA, is seeking a Clinical Trial Manager to oversee clinical operations and site-level activities for studies in coronary artery disease. You will collaborate with Clinical Research staff, investigators, vendors, and Heartflow teams to drive timelines, quality, and compliance.

The CTM will manage study sites, develop timelines, and lead process improvements while ensuring adherence to GCP and regulatory requirements.

Qualifications

• Bachelor's degree in science or health-related field required.
• Minimum 5 years of relevant experience required.
• Experience in cardiovascular medical device clinical research is a plus.

Responsibilities

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks.
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development.
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs.
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management.
• Perform other duties as required for successfully completing studies, as necessary.

Skills

Clinical research

Project management

Documentation

Regulatory knowledge

English communication

MS Office

Education

Bachelor's degree in science

Job description

Heartflow, a medical technology company based in Pittsburgh, PA, is seeking a Clinical Trial Manager to oversee clinical operations and site-level activities for studies in coronary artery disease. You will collaborate with Clinical Research staff, investigators, vendors, and Heartflow teams to drive timelines, quality, and compliance.

The CTM will manage study sites, develop timelines, and lead process improvements while ensuring adherence to GCP and regulatory requirements.