Heartflow
medical technology
ClinicalTrialManager
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“Clinical Trial Manager at Heartflow. Skills: oversight and management of all clinical operational activities at the trial and site level, clinical research study execution, vendor management, project management tasks, Develops clinical trial timelines, enrollment projections, process improvement activities, study start-up activities, ensure compliance with study requirements and GCPs, Maintain effective working relationships with investigators/investigational site research coordinators, and vend”
Industry & Context.
risk mitigation
Travel required: up to 25%
What They're Looking For.
Must Have
Demonstrated 5 years minimum relevant experience required, Bachelor’s degree in science or health related field, 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
Nice to Have
Experience in cardiovascular medical device clinical research a plus
What You'll Do.
oversight and management of all clinical operational activities at the trial and site level
Participates in clinical research activities including management of clinical study sites
management of study documentation
and completion of project management tasks
Develops clinical trial timelines
enrollment projections
and instructional materials in support of trial execution
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
Reviews site regulatory documents (informed consents
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
How You'll Work.
Team & Collaboration
interact well with the Heartflow Clinical Research staff; collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors; Participates in and leads process improvement activities within the department and cross functionally; Ability to work in a smaller team environment; Maintains effective working relationships with investigators/investigational site research coordinators, and vendors
Communication Scope
Excellent written and oral English communication skills required
Process & Methodology
completion of project management tasks, Develops clinical trial timelines, enrollment projections, project plans, communication plans, monitoring plans, recruitment plans, risk mitigation plans, contingency plans
Full Job Description
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide. This position is open for the Central Midwest region, with targeted cities but not limited to: Chicago, Illinois; Minneapolis, Minnesota; Dallas, Texas; Houston, Texas; Austin, Texas. The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fas
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