The Director of Clinical Operations at Ceribell will be a pivotal leader responsible for overseeing all aspects of clinical operations, including both prospective and retrospective (e.g., medical records) studies. This role includes the preparation of protocols and other study materials, site qualification, navigation of IRB processes, patient enrollment, data monitoring, and data management. The Director will ensure that all internal processes comply with regulatory standards and may also contribute to clinical and regulatory strategy development.

What you’ll do: 

• Protocol Development:
• Lead the development and preparation of clinical trial protocols, informed consent forms, and other essential study documents.
• Ensure that all study materials align with regulatory requirements and company standards.
• Site Qualification & Management:
• Identify, evaluate, and qualify clinical trial sites.
• Build and maintain strong relationships with site investigators and staff.
• IRB Process Navigation:
• Manage and oversee Institutional Review Board (IRB) submissions and approvals.
• Ensure all studies adhere to ethical standards and regulatory guidelines.
• Patient Enrollment & Retention:
• Develop and implement strategies for patient recruitment and retention.
• Monitor enrollment progress and address any challenges to ensure study timelines are met.
• Data Monitoring & Management:
• Oversee data collection, monitoring, and management activities to ensure data integrity and compliance.
• Collaborate with data management teams to ensure accurate and timely reporting of study data.
• Compliance & Quality Assurance:
• Ensure all clinical operations comply with applicable regulatory requirements, Good Clinical Practice (GCP), and company policies.
• Conduct regular quality checks and audits to maintain high standards of clinical practice.
• Strategic Contribution:
• Provide input on clinical and regulatory strategy to support product development and commercialization efforts.
• Collaborate with cross-functional teams to align clinical operations with overall business objectives.

What you need to be successful: 

• Advanced degree (preferred) in a relevant scientific or medical field (e.g., MD, PhD, PharmD).
• Minimum of 8-10 years of experience in clinical operations within the medical device industry.
• Demonstrated experience in protocol development, site management, IRB processes, patient enrollment, and data management.
• Strong understanding of regulatory requirements and Good Clinical Practice (GCP).
• Excellent leadership, communication, and interpersonal skills.
• Ability to manage multiple projects simultaneously and meet deadlines.
• Strategic thinker with the ability to contribute to clinical and regulatory planning.

Preferred qualifications:

• Demonstrated experience managing retrospective studies such as medical records and real-world data studies.

A candidate’s final salary offer will be based on their skills, education, work location and experience, and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribell’s corporate compensation plan. Note, the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.

Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status or any other characteristic protected by law. Any applicant with a disability who requires an accommodation during the application process should contact [email protected] to request reasonable accommodation.