Clinical Trial Manager at HeartFlow

New York, New York, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Technology, HealthcareIndustries

Requirements

Bachelor’s degree in science or health related field
Demonstrated 5 years minimum relevant experience required
Experience in cardiovascular medical device clinical research a plus
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
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
Willingness to travel up to 25%

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

Clinical Trial Management

Site Management

Vendor Management

Clinical Research

Project Management

GCP

Regulatory Compliance

HeartFlow

Non-invasive cardiac testing for heart disease

About HeartFlow

HeartFlow provides a non-invasive cardiac test that helps visualize a patient's coronary arteries in detail. This technology allows physicians to diagnose and treat heart disease more effectively without the need for invasive procedures, which reduces risks for patients and costs for healthcare providers. HeartFlow's main clients are healthcare professionals seeking safer diagnostic methods. The company offers several analyses, including FFRCT Analysis and Plaque Analysis, all of which have received FDA clearance and are available in multiple countries, including the United States, the United Kingdom, Japan, and Canada. Unlike many competitors, HeartFlow focuses on providing a comprehensive suite of analyses that enhance treatment planning. The goal of HeartFlow is to improve cardiovascular care by making it safer and more efficient for both patients and healthcare providers.

Redwood City, CaliforniaHeadquarters

2010Year Founded

$858.5MTotal Funding

SERIES_FCompany Stage

HealthcareIndustries

501-1,000Employees

Benefits

Remote Work Options

Stock Options

401(k) Company Match

Risks

Emerging AI-driven competitors could threaten HeartFlow's market share.

Algorithmic bias in AI models could lead to inaccurate diagnoses.

Integration into healthcare systems may face resistance due to complexity and cost.

Differentiation

HeartFlow offers the only combined anatomy, physiology, and plaque analysis for heart disease.

HeartFlow's non-invasive FFRCT Analysis is FDA-cleared and widely available globally.

HeartFlow's AI-driven technology provides personalized 3D heart models for precise diagnostics.

Upsides

HeartFlow closed a $215 million Series F funding round in April 2023.

The global non-invasive cardiac imaging market is projected to grow significantly.

HeartFlow's technology aligns with the trend towards value-based care in healthcare.

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