Heartflow
Clinical Trial Manager - West Coast
Heartflow, San Francisco, California, United States, 94199
Overview
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using AI-driven technology. The Heartflow FFRCT Analysis provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on heart blood flow. Heartflow’s suite supports the CCTA pathway to identify stenoses, assess coronary blood flow, and characterize and quantify coronary atherosclerosis. The Clinical Trial Manager (CTM) oversees and manages all clinical operational activities at the trial and site level, collaborating with Heartflow Clinical Research staff, onsite and field teams, coordinators, principal investigators, and vendors to ensure trials meet timelines and quality standards. The CTM will work in a fast-paced start-up environment with demonstrated experience in clinical research study execution and strong organizational skills. Job 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 to support trial execution, including project planning, communications, 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, coordinators, and vendors including core labs and data management Performs other duties as required for successfully completing studies Skills Needed
Ability to work in a smaller team environment with an all-hands-on-deck attitude Ability to manage multiple tasks and adapt to shifting priorities High attention to detail, accuracy, and quality and the 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 Microsoft Word, Excel, and PowerPoint Educational Requirements & Work Experience
Bachelor’s degree in science or health-related field Demonstrated 5 years minimum relevant experience Experience in cardiovascular medical device clinical research is a plus Travel
Travel up to 25% Salary
A reasonable estimate of the base salary compensation range is $110,000 to $150,000 (San Francisco Bay Area) plus cash bonus. Equal Opportunity Employer
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. Positions posted for Heartflow are not intended for or open to third party recruiters/agencies. Submission of unsolicited resumes will be considered free referrals. Heartflow also warns about fraud where unknown entities pose as Heartflow recruiters; verify legitimate Heartflow recruiter email addresses ending with @heartflow.com and ensure the position is listed on the careers site at www.heartflow.com/about/careers/.
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Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using AI-driven technology. The Heartflow FFRCT Analysis provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on heart blood flow. Heartflow’s suite supports the CCTA pathway to identify stenoses, assess coronary blood flow, and characterize and quantify coronary atherosclerosis. The Clinical Trial Manager (CTM) oversees and manages all clinical operational activities at the trial and site level, collaborating with Heartflow Clinical Research staff, onsite and field teams, coordinators, principal investigators, and vendors to ensure trials meet timelines and quality standards. The CTM will work in a fast-paced start-up environment with demonstrated experience in clinical research study execution and strong organizational skills. Job 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 to support trial execution, including project planning, communications, 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, coordinators, and vendors including core labs and data management Performs other duties as required for successfully completing studies Skills Needed
Ability to work in a smaller team environment with an all-hands-on-deck attitude Ability to manage multiple tasks and adapt to shifting priorities High attention to detail, accuracy, and quality and the 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 Microsoft Word, Excel, and PowerPoint Educational Requirements & Work Experience
Bachelor’s degree in science or health-related field Demonstrated 5 years minimum relevant experience Experience in cardiovascular medical device clinical research is a plus Travel
Travel up to 25% Salary
A reasonable estimate of the base salary compensation range is $110,000 to $150,000 (San Francisco Bay Area) plus cash bonus. Equal Opportunity Employer
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. Positions posted for Heartflow are not intended for or open to third party recruiters/agencies. Submission of unsolicited resumes will be considered free referrals. Heartflow also warns about fraud where unknown entities pose as Heartflow recruiters; verify legitimate Heartflow recruiter email addresses ending with @heartflow.com and ensure the position is listed on the careers site at www.heartflow.com/about/careers/.
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