Clinical Trial Manager
The CTM is responsible for the oversight and management of clinical operational activities at the trial and site level. The role interacts with the HeartFlow Clinical Research staff and collaborates 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. This position 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.
- Responsible for leading clinical studies with new and existing Japanese sites and new sites, keeping in alignment with headquarters and collaborating with the HFJ commercial team.
- Handle requests from customers for investigator initiated studies with thorough internal investigation for appropriateness. Ability to assess alignment with company’s global strategy for handling clinical study and HeartFlow Japan’s marketing strategy and priority is essential. Directly responsible for tracking these investigator-initiated studies originating in Japan as assigned.
- Establish robust relationships with counterparts in headquarters.
- Manage vendors and CRO activities. Track internal and external (CRO/vendor) project deliverables to ensure they remain within timeline and budget
- Participate in clinical research activities including management of clinical study sites, management of study documentation, upkeep of clinical trackers, and completion of project management tasks
- Develop clinical trial timelines, enrollment projections, and instructional materials in support of trial execution (including project, communication, monitoring, recruitment, risk mitigation, and contingency plans)
- Conduct study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
- Review site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
- Manage site budgets, contracts, invoices, and payments
- Maintain effective working relationships with investigators/investigational site research coordinators, and vendors (including core labs, data management, and CROs)
- Perform other duties as required for successfully completing studies
- Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
- Fundamental knowledge of legal regulations and deep understanding for procedures related to clinical studies
- High-level knowledge of mandatory procedures to conduct clinical study for medical devices
Educational Requirements & Work Experience:
- Bachelor’s degree required
- Minimum 5 years of medical device industry experience in clinical affairs
- Experience conducting clinical trials (company sponsored or investigator initiated) for medical devices from study start up through database lock
- Cardiology related and medical imaging products experience is preferable
- Fluent in English (TOEIC or equivalent of 700 or more)
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.