Cardio Clinical Trial Lead for AI-Powered Diagnostics

Heartflow; Washington (District of Columbia); On-site; USD 95,000 - 125,000; Full time

Job summary

Heartflow is seeking a Clinical Trial Manager (CTM) to oversee clinical operations at trial sites and manage study documentation, vendor coordination, and cross-functional tasks in a fast-paced start-up environment.

The role requires 5+ years of experience in clinical research, knowledge of ICH/GCP, and strong organizational skills. The CTM will collaborate with Heartflow Clinical Research staff and external partners, with travel up to 25%.

Qualifications

• Bachelor's degree in science or health related field.
• Demonstrated 5 years minimum relevant experience.
• Experience in cardiovascular medical device clinical research a plus.

Responsibilities

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and 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

Team collaboration

Multitasking

Attention to detail

ICH Guidelines & FDA regulations

English communication

MS Office

Education

Bachelor's degree in science or health related field

Tools

Microsoft Office Suite

Job description

Heartflow is seeking a Clinical Trial Manager (CTM) to oversee clinical operations at trial sites and manage study documentation, vendor coordination, and cross-functional tasks in a fast-paced start-up environment.

The role requires 5+ years of experience in clinical research, knowledge of ICH/GCP, and strong organizational skills. The CTM will collaborate with Heartflow Clinical Research staff and external partners, with travel up to 25%.