Clinical Operations Manager

Moon Surgical • San Carlos, CA

289d

About The Position

At Moon Surgical, we are redefining the standard of care in minimally invasive surgery by equipping operating rooms with the Maestro System-a digital surgical assistant designed to enhance efficiency, and workflow in minimally invasive surgery. Our mission is to profoundly change the surgical landscape, ensuring that clinicians can perform laparoscopic procedures with greater confidence, consistency, and control, across hospital outpatient departments (HOPDs), ambulatory surgery centers (ASCs), and other care settings. We are looking for an experienced Clinical Operations Manager to lead and execute clinical evidence generation activities, playing a pivotal role in advancing the adoption of the Maestro System. The ideal candidate will drive the execution of clinical research initiatives and post-market studies, manage site selection and engagement, coordinate with investigators, ensure protocol execution and supervise data analysis and scientific communications, while maintaining compliance with Good Clinical Practice (GCP) guidelines and global investigational device regulations when appropriate. This role requires an individual with strong leadership skills and experience in clinical, operation, and quality improvement research.

Requirements

• Bachelors or Masters of Science.
• Project Management including timeline development, risk mitigation, and cross functional coordination.
• 5+ years of experience in clinical trial or research management, within a healthcare provider facility, or the medical device industry with a preference for robotics, laparoscopy, or minimally invasive surgery.
• Experience in cross-functional collaboration, working with surgeons, clinical teams, regulatory bodies, and commercial teams.
• Strong understanding of statistics and data analysis with tools like excel.
• Prior experience running research programs in HOPDs and ASCs is highly desirable.
• Strong knowledge of clinical study design, GCP, ISO 14155, and U.S./international regulatory guidelines for investigational devices.

Responsibilities

• Oversee all aspects of clinical research and post-market studies, including operational and quality improvement studies, for the Maestro System, ensuring they are conducted efficiently, within scope, and on schedule.
• Lead investigator engagement, site selection, preparation, and execution across HOPDs, ASCs, and hospital settings.
• Establish clinical research agreements with each site, and ensure appropriate documentation of regulatory approvals, site credentials, and compliance with investigational regulations.
• Ensure sites are properly trained on Maestro's technology and study protocols, maintaining close collaboration with surgeons, OR teams, and research staff.
• Develop data collection strategies, manage their implementation, and ensure the accuracy, completeness, and traceability of study records.
• Schedule and oversee site monitoring visits to assess study compliance and performance.
• Supervise data analytics.
• Prepare scientific communications in line with company goals.
• Build and maintain strong relationships with key clinical stakeholders, including surgeons, OR staff, study coordinators, and hospital administrators.
• Serve as the primary liaison between research sites and Moon Surgical's internal teams, ensuring effective communication and issue resolution.
• Ensure that any investigational products are tracked, accounted for, and compliant with regulatory requirements at study sites.
• Support real-world evidence generation to drive Maestro's adoption strategy.
• Manage execution of Moon Surgical's clinical evidence generation plan.
• Work closely with R&D, regulatory, marketing, and commercial teams to align clinical research with broader company objectives.
• Drive continuous improvement in clinical operations efficiency, processes, and study execution strategies.
• Oversee clinical trial budgeting, contracts, and invoicing, ensuring alignment with financial and operational goals.
• Provide senior management with regular status updates on research progress, risks, and key learnings.

Benefits

• 25 Days of Paid Vacation
• 10 Paid Holidays
• 401k with matching
• Competitive Vision, Dental, and Health benefits
• Regular national and international travel required

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees