Clinical Trial Manager
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 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 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.
- Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget
- Participates in clinical research activities including management of clinical study sites, management of study documentation, and completion of project management tasks
- Develops clinical trial timelines, enrollment projections, documents 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 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/investigational site research coordinators, and vendors including core labs, data management, and CROs
- Upload cases and enter biometrics for assigned clinical studies, as required
- Perform other duties as required for successfully completing studies, as necessary
- Some travel required; will occasionally conduct site visits, attend investigator meetings, or vendor visits/audits
- 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; Access a plus
Educational Requirements & Work Experience:
- Bachelor’s degree in science or health related field
- Demonstrated 3-5 years minimum relevant experience required
- Experience in cardiovascular medical device clinical research a plus
- Experience in registry studies and investigator-initiated studies a plus
About HeartFlow, Inc.
HeartFlow, Inc. is a medical technology company redefining the way heart disease is diagnosed and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, Canada, Europe and Japan. For more information, visit www.heartflow.com.
HeartFlow, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.
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.