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Clinical Data Associate
2 months ago
HeartFlow, Inc. 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 (RoadMapTMAnalysis), 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 VC-backed, pre-IPO company 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 250,000 patients worldwide.
The Clinical Data Associate (CDA) is responsible for the oversight and management of all clinical data activities for a variety of different clinical trials and data associated with these trials. The CDA 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 ensure clinical studies meet or exceed timelines and maintain high quality standards. The CDA will have demonstrated experience managing different kinds of data for clinical trials, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture. This position will be remote with a preference to be based within driving distance of the Mountain View, CA office unless otherwise agreed upon. #LI-IB1
Job Responsibilities:
- Manages project deliverables to ensure they remain within the timeline and budget
- Develops timelines for data management activities, enrollment projections, and creates/modifies/reviews instructional materials in support of trial execution, including project and data management plans
- Oversees the development of any clinical database by the EDC/CRO vendor, and will manage the sponsor user acceptance testing of the clinical database
- Upload cases and enter biometrics for assigned clinical studies, as required
- Participates in and leads process improvement activities within the department and cross functionally, including SOP development
- Works with other clinical research team members on study start-up activities including the development and review of case report forms, source document worksheets, training presentations, etc.
- Examines and resolves data inconsistencies within specified timelines that may be urgent in nature
- Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, consultants, and CROs
- Works in coordination with statisticians, programmer/analysts, clinical research team members, and other team members as required
- Acts as point of contact for data management in all meetings relating to a study
- Perform other duties as required for successfully completing studies, as necessary
- Some travel may be required; may occasionally attend investigator meetings, or vendor visits/audits
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
- Flexibility and willingness to learn new techniques and procedures to ensure the successful completion of 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; SAS a plus; Python a plus
Educational Requirements & Work Experience:
- Bachelor's degree in science or health related field
- Demonstrated 2-4 years minimum relevant experience required
- Experience in cardiovascular medical device clinical research a plus
- Experience in registry studies and investigator-initiated studies a plus
A reasonable estimate of the yearly base compensation range is $80,000 to $110,000, cash bonus, and stock options.
HeartFlow, Inc. 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 any unsolicited resumes for these positions will be considered to be free referrals.
