Senior Clinical Trial Manager

Capstan Medical; California (MO); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading company in medical devices is seeking a Senior Clinical Trial Manager to lead pre-market studies for innovative valve repair products. The role requires extensive experience in clinical trials, regulatory compliance, and excellent project management skills. You will collaborate with various teams to ensure successful study execution and data accuracy. If you have a strong background in clinical research and are looking for a fast-paced environment, this opportunity is for you.

Qualifications

• Minimum 8 years of clinical trial experience in medical devices.
• Experience managing clinical trials and knowledge of regulations.

Responsibilities

• Lead pre-market clinical studies for medical devices.
• Manage clinical research organizations and oversee study progress.
• Ensure regulatory compliance and track clinical study data.

Skills

Communication

Organizational Skills

Project Management

Problem Solving

Microsoft Office Suite

Electronic Data Capture

Education

Clinical Research Certification

Job description

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This range is provided by Capstan Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $200,000.00/yr

The Opportunity:

We are seeking a Sr. Clinical Trial Manager to lead pre-market 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, including Good Clinical Practice (ISO 14155), 21 CFR parts 50, 54, 812, and other relevant regulations. As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to execute clinical studies with minimal supervision. Close cooperation with engineering, regulatory teams, biostatisticians, and other departments will be essential. Experience in reviewing, interpreting, and summarizing clinical literature is expected. The role is fast-paced and evolving, requiring excellent organizational and project management skills.

What you’ll do:

• 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 (CROs) involved with the study.
• Oversee site start-up/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.

What you’ll need:

Skills

• Prior clinical setting experience required.
• 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.

Requirements

• A minimum of 8 years of clinical trial experience within the medical device industry.
• Previous experience in managing and implementing medical device trials (Pharma not preferred).
• In-depth knowledge of clinical and outcomes research study design.
• Advanced knowledge of clinical investigation of medical devices for human subjects, including 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 or education.
• Ability to work onsite in Santa Cruz as needed.
• Knowledge of medical terminology.
• Knowledge of statistics, statistical methods, and experiment design is highly preferred.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.