Clinical Trial Manager - Investigator Initiated Studies

Heartflow; Orlando (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Heartflow is seeking a Clinical Trial Manager (CTM) - Investigator Initiated Studies to oversee clinical operational activities for investigator initiated studies. The CTM will work with Heartflow Clinical Research staff, onsite and field staff, coordinators, principal investigators, and vendors to ensure studies meet timelines and quality.

The successful candidate will have 5+ years of clinical research experience, knowledge of ICH and FDA/European requirements, and strong organizational skills

Qualifications

• Bachelor’s degree in science or health related field.
• Minimum 5 years of relevant clinical research experience.
• Experience managing investigator initiated studies a plus.
• Experience in cardiovascular medical device clinical research a plus.

Responsibilities

• 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 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 leading study kick off meetings, contract management, and site onboarding and training.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) as needed 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.
• Track internal and external project deliverables to ensure they remain within the timeline and budget.
• Perform other duties as required for successfully completing studies, as necessary.

Skills

Clinical trial management

Investigator Initiated Studies

Vendor management

Project coordination

ICH/GCP knowledge

FDA/European regulatory knowledge

English communication

MS Office proficiency

Education

Bachelor's degree in science or health related field

Tools

Microsoft Office

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 750,000 patients worldwide.

The Clinical Trial Manager (CTM) - Investigator Initiated Studies is responsible for the oversight and management of all clinical operational activities for investigator initiated studies. 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 fast-paced start-up culture.

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 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 leading study kick off meetings, contract management, and site onboarding and training.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) as needed 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.
• Track internal and external project deliverables to ensure they remain within the timeline and budget.
• Perform other duties as required for successfully completing studies, as necessary.

Skills Needed

• 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

Educational Requirements & Work Experience

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience managing investigator initiated studies a plus
• Experience in cardiovascular medical device clinical research a plus

A reasonable estimate of the base salary compensation range is $90,000 to $130,000 and 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.