Clinical Trial Manager - Investigator Initiated Studies

The role

The Clinical Trial Manager oversees and manages all clinical operational activities for investigator initiated studies. This role involves collaborating with clinical research staff, investigators, and vendors to ensure studies meet timelines and quality standards.

What you will do

• Manages clinical study sites, study documentation, vendor management, and project management tasks.
• Develops clinical trial timelines, enrollment projections, and instructional materials.
• Participates in and leads process improvement activities and SOP development.
• Conducts study start-up activities including kick off meetings, contract management, and site onboarding.
• Reviews site regulatory documents to ensure compliance with study requirements and GCPs.
• Maintains working relationships with investigators, research coordinators, and vendors.
• Tracks internal and external project deliverables to ensure they remain within timeline and budget.
• Performs other duties as required for successfully completing studies.

Required qualifications

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience
• Ability to work in a smaller team environment
• Ability to manage multiple tasks and shifting priorities
• High attention to detail, accuracy, and quality
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills
• Proficiency in Microsoft office tools including Word, Excel and PowerPoint

Nice to have

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

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven technology. It is a publicly traded company cleared for use in the US, UK, Europe, Japan and Canada.