Clinical Trial Manager
Posted on 3/22/2024
HeartFlow

501-1,000 employees

Non-invasive cardiac diagnostic technology for physicians
Company Overview
HeartFlow, Inc. is a leading medical technology company that is reshaping cardiovascular care through its non-invasive HeartFlow Analysis, which aids physicians in making more informed care decisions for patients with suspected coronary artery disease. The company's competitive advantage lies in its robust scientific research and development, and its use of advanced technology like deep learning and computational fluid dynamics, which has led to its recognition and clearance in multiple countries including the United States, Canada, Europe, and Japan. With a strong commitment to improving patient safety and reducing healthcare costs, HeartFlow fosters a culture that values passion for its mission, making it an attractive workplace for those seeking to make a significant impact in the healthcare industry.
AI & Machine Learning
Data & Analytics

Company Stage

Series F

Total Funding

$1.2B

Founded

2010

Headquarters

Mountain View, California

Growth & Insights
Headcount

6 month growth

8%

1 year growth

12%

2 year growth

31%
Locations
Austin, TX, USA • Mountain View, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
CategoriesNew
Medical, Clinical & Veterinary
Healthcare Administration & Support
Nursing & Allied Health Professionals
Requirements
  • Bachelor's degree in science or health related field
  • 3-5 years minimum relevant experience
  • Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
  • Experience in cardiovascular medical device clinical research a plus
  • Experience in investigator-initiated studies preferred
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