Overview
Title: Clinical Trial Manager
Reports to: Clinical Fellow
Location: Hybrid
Salary Range: $150-200K, depending upon experience
About us:
At Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz, which gives us access to the amazing technical talent of the Bay Area, but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment!
Description
We are seeking a Clinical Trial Manager to lead premarket clinical studies for Capstan Medical and Versa Vascular mitral and tricuspid valve repair products. The ideal candidate should be well-versed in Clinical investigation of medical devices for human subjects – Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, and other relevant regulations.
As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to execute clinical studies. Strong cross-functional work with engineering, regulatory teams, biostatisticians, and other departments will be essential for this role. Experience in reviewing, interpreting, and summarizing clinical literature is expected. The role is fast-paced and evolving, requiring excellent organizational and project management skills.
- Support all clinical research activities to ensure effective management of clinical studies.
- Maintain and track clinical study data, assist in investigator qualification and selection, monitor patient recruitment, and oversee study progress.
- Manage clinical research organizations (CRO) involved with the study.
- Oversee site startup/activation processes, including preparing study documents such as protocols, CRFs/eCRFs, informed consent forms, and clinical monitoring plans.
- Organize IRB/EC submissions and ensure regulatory compliance for successful outcomes.
- Amend clinical study documents as needed and assist clinical sites with institutional review board submissions.
- Perform on-site and remote site qualification, initiation, interim monitoring, and close-out visits.
- Conduct clinical study monitoring to ensure compliance with regulations and protocols, ensuring data accuracy.
- Verify source data of clinical study data in EDC systems or case report forms at sites.
- Serve as the main liaison for participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking, and accountability.
- Drive safety event reviews and develop necessary narratives and reports. Manage CEC and DSMB if applicable
- Manage trial master files, maintain study documentation, and clinical trial management systems.
- Track and process site payments, develop tracking tools as necessary, and assist in study financial tracking.
- Develop pre-study questionnaires, study designs, and assist in physician/site selection.
Skills
- Previous experience in managing and implementing medical device trials.
- In-depth knowledge of clinical and outcomes research study design.
- Advanced knowledge of Clinical investigation of medical devices for human subjects – Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812, and other relevant regulations.
- Familiarity with ICH/GCP guidelines and other applicable regulations.
- Preferred clinical research/clinical trial management certification/education.
- Prior clinical setting experience preferred.
- Strong ability to interact with physicians and professionals inside and outside the company.
- Experience in protocol and ICF development, writing clinical sections for regulatory submissions.
- Experience negotiating clinical research contracts and budgets.
- Experience managing a clinical events committee and data safety monitoring board.
- Ability to work effectively on cross-functional teams and manage multiple projects and priorities.
- Excellent communication, presentation, and organizational skills with high attention to detail.
- Ability to learn quickly and self-educate on various surgical specialties applicable to clinical projects.
- Ability to manage CROs and provide relevant study updates to management.
- Strong work ethic to meet tight timelines or manage multiple projects with a problem-solving mindset.
- Proficiency in Microsoft Office Suite and PDF applications.
- Experience with electronic data capture (EDC) systems required.
- Required experience in the medical device industry.
Education and Training
- A minimum of 8 years of medical device clinical trials experience
- Microsoft Office proficiency
- Ability to work onsite in Santa Cruz as needed
- Knowledge of medical terminology.
- Knowledge of statistics, statistical methods, and experiment design is highly preferred.