Note: The job is a remote job and is open to candidates in USA. Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The Clinical Trial Manager will oversee and manage all clinical operational activities at the trial and site level, ensuring studies meet timelines and maintain high quality standards.

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

• Bachelor's degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint
• Experience in cardiovascular medical device clinical research a plus

Benefits

• Cash bonus

Company Overview

Company H1B Sponsorship