Clinical Trial Manager (Hybrid) at HeartFlow

San Francisco, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Technology, Healthcare InnovationIndustries

Requirements

Candidates must possess a Bachelor's degree in a science or health-related field and have a minimum of 5 years of relevant experience in clinical research study execution. A strong understanding of ICH Guidelines, US FDA, and European clinical trial regulations is essential, along with excellent written and oral English communication skills and proficiency in Microsoft Office Suite. Experience in cardiovascular medical device clinical research is a plus, and the ability to manage multiple tasks in a fast-paced, shifting-priority environment is required. Up to 25% travel may be necessary.

Responsibilities

The Clinical Trial Manager is responsible for overseeing and managing all clinical operational activities at the trial and site level, including site management, documentation, and vendor management. They will develop clinical trial timelines, enrollment projections, and instructional materials, and participate in process improvement activities and SOP development. Responsibilities also include conducting study start-up activities, reviewing site regulatory documents for compliance, and maintaining effective working relationships with investigators, site staff, and vendors.

Skills

Clinical Trial Management

Clinical Research

Study Management

Organizational Skills

Attention to Detail

Communication

Vendor Management

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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