Clinical Trials Lead – Investigator-Initiated Studies

Heartflow; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

Heartflow is seeking a Clinical Trial Manager (CTM) - Investigator Initiated Studies to oversee clinical operational activities for investigator initiated studies. The CTM will work with HeartFlow Clinical Research staff and collaborate with onsite and field staff, coordinators, principal investigators, and vendors to ensure studies meet timelines and maintain high quality standards.

Responsibilities include managing study sites, developing timelines, enrollment projections, SOPs, start-up

Qualifications

• Bachelor’s degree in science or health related field.
• Minimum 5 years relevant experience in clinical research.
• Experience managing investigator initiated studies is a plus.
• 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 for trial execution.
• Leads process improvement activities and SOP development.
• Conducts study start-up activities including kick-off meetings, contract management, and site onboarding and training.
• Reviews regulatory documents (informed consents, IRB approvals, research agreements) for compliance.
• Maintains relationships with investigators, coordinators, vendors.
• Tracks project deliverables within timeline and budget.
• Performs other duties as required.

Skills

Attention to detail

Project management

Healthcare/clinical research

English communication

Microsoft 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) - Investigator Initiated Studies to oversee clinical operational activities for investigator initiated studies. The CTM will work with HeartFlow Clinical Research staff and collaborate with onsite and field staff, coordinators, principal investigators, and vendors to ensure studies meet timelines and maintain high quality standards.

Responsibilities include managing study sites, developing timelines, enrollment projections, SOPs, start-up