Clinical Operations Manager

Location: San Francisco Bay Area, CA

Full Time

Role Overview

 As the Clinical Operations Manager, you will play a central role in ensuring our clinical trials are executed with rigor, efficiency, and compliance. You will manage trial operations end-to-end, including site activation, monitoring, data flow, CRO/vendor oversight, and regulatory compliance. This is a hands-on, execution-focused role that will directly support the success of Sanmai’s pivotal clinical studies. The Clinical Operations Manager will report to the Chief Clinical Officer (CCO).

What You Will Achieve

As Clinical Operations Manager at Sanmai, you will:

  • Ensure pivotal trial readiness by driving site activation, monitoring, and compliance.

  • Deliver accurate, audit-ready data to support regulatory submissions.

  • Maintain the highest standards of participant safety and ethical practice.

  • Play a critical role in building the operational foundation for Sanmai’s clinical success.

Responsibilities

Clinical Trial Execution

  • Lead site activation, training, and monitoring across multi-site trials.

  • Oversee CROs, vendors, and external partners to ensure milestones, budgets, and deliverables are met.

  • Manage participant recruitment and retention processes in collaboration with sites.

Data & Compliance

  • Ensure all documentation is accurate, audit-ready, and compliant with FDA, IRB, HIPAA, and GCP standards.

  • Support regulatory filings (IND, IDE, De Novo) by providing accurate and timely trial data.

  • Implement and maintain strong data capture and reporting practices.

Operations Management

  • Serve as day-to-day liaison between sites, CROs, and Sanmai’s internal clinical team.

  • Track and report on trial progress, risks, and key metrics.

  • Troubleshoot operational barriers to keep studies on track.

Qualifications

 Experience:

  • 3–5+ years in clinical research operations, ideally in medtech, neuroscience, or mental health.

  • Proven track record in site management, monitoring, and trial execution.

  • Experience with FDA-regulated clinical trials.

Skills:

  • Strong organizational and project management skills.

  • Knowledge of clinical trial management systems, EDC tools (e.g., REDCap), and regulatory requirements.

  • Excellent communication skills, able to coordinate across diverse stakeholders.

Education:

  • Master’s or PhD in life sciences, psychology, biomedical engineering, clinical research, or related field.

Attributes:

  • Hands-on operator who thrives in a fast-paced, mission-driven environment.

  • Detail-oriented, execution-focused, and committed to participant safety.

  • Deep sense of ethics and respect for human subjects research.