Clinical Trial Manager - West Coast

Overview

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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 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 with Heartflow Clinical Research staff and collaborate with onsite and field staff, clinical research coordinators, principal investigators, and vendors to help ensure clinical studies meet or exceed timelines and maintain high quality standards.

The CTM should have demonstrated experience with clinical research study execution, strong organizational skills, attention to detail, and the ability to work in a fast-paced startup environment.

• Participates in clinical research activities including management of clinical study sites, study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials to support trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Leads process improvement activities within the department and cross-functionally, including SOP development
• Conducts study start-up activities including development of protocols, informed consent forms, source document worksheets, and training materials
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators, site research coordinators, and vendors including core labs and data management
• Performs other duties as required for successfully completing studies, as necessary

• Ability to work in a smaller team environment with a hands-on attitude
• Ability to manage multiple tasks and adapt to shifting priorities
• High attention to detail, accuracy, and quality with ability to prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills
• Proficiency in computer programs, including Microsoft Word, Excel, and Power Point

• Bachelor’s degree in science or health-related field
• Minimum of 5 years relevant experience
• Experience in cardiovascular medical device clinical research is a plus

Travel required:

up to 25%

A reasonable base salary range estimate is $110,000 to $150,000 (San Francisco Bay Area) plus cash bonus. Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

Heartflow has become aware of fraud where unknown entities pose as Heartflow recruiters in an attempt to obtain personal information. Before providing any personal information, please verify:

A) legitimate Heartflow recruiter emails end with  and

B) the position is listed on our careers site at

IsExpired: false