Ceribell, Inc
Overview
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform designed to address the unmet needs of patients in the acute care setting and is used in hundreds of community hospitals, large academic facilities and major IDNs across the country. Our team is committed to transforming the landscape of critical care through rapid seizure detection technology. What You'll Do
Study Monitoring: Perform site qualification, initiation, monitoring, and close-out visits. Ensure adherence to protocol, GCP, ISO 14155, and applicable regulations. Verify that study data is accurate, complete, and verifiable from source documents. Track enrollment and site performance metrics. Regulatory Compliance: Ensure regulatory submissions and approvals are in place before trial initiation. Maintain knowledge of FDA and other global regulations relevant to medical device trials. Site Management: Serve as the primary point of contact for clinical sites. Provide training to site staff on study protocols and data collection systems. Manage and resolve site issues and queries promptly. Support preparation and maintenance of clinical trial documentation such as the Trial Master File (TMF), site binders, and site regulatory documentation. Documentation & Reporting: Maintain TMF documentation in compliance with SOPs. Draft monitoring reports, follow-up letters, and site visit summaries. Assist in the development of study protocols, CRFs, ICFs, and other clinical documents. Cross-functional Collaboration: Work closely with clinical project managers, regulatory affairs, quality assurance, and R&D. Support clinical strategy discussions and device lifecycle planning. What We're Looking For
Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or related field. 3+ years of experience monitoring clinical trials, preferably in the medical device industry, with sponsor-side exposure. Experience working in Neuroscience space. Strong understanding of ISO 14155, FDA 21 CFR Part 812, and ICH-GCP guidelines. Experience with EDC systems (e.g., TrialMaster, REDCap, or similar). Strong attention to detail and ability to manage multiple priorities under pressure. Proficient in Microsoft Office and Teams; familiarity with Google Workspace and Dropbox is a plus. Excellent written and verbal communication skills. Willingness to travel up to 30%. Preferred Qualifications
Master’s degree or advanced clinical/scientific training. Experience with Class II or III medical devices. Certification (e.g., ACRP, SOCRA) is a plus. Salary Range
SF Bay Area/NY Metro/LA Metro: $134,000 - $164,000 per year National: $107,000 - $128,500 per year In Addition to Your Base Compensation
Annual Bonus + Equity Opportunity 100% Employer paid Health Benefits for Employees 100% paid Life and Long-Term Disability Insurance 401(k) with a generous company match Employee Stock Purchase Plan (ESPP) with a discount Monthly cell phone stipend Flexible paid time off 11 Paid Holidays + 5 Company Wellness Days Excellent parental leave policy Fantastic culture with tremendous career advancement opportunities Joining a mission-minded organization
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Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform designed to address the unmet needs of patients in the acute care setting and is used in hundreds of community hospitals, large academic facilities and major IDNs across the country. Our team is committed to transforming the landscape of critical care through rapid seizure detection technology. What You'll Do
Study Monitoring: Perform site qualification, initiation, monitoring, and close-out visits. Ensure adherence to protocol, GCP, ISO 14155, and applicable regulations. Verify that study data is accurate, complete, and verifiable from source documents. Track enrollment and site performance metrics. Regulatory Compliance: Ensure regulatory submissions and approvals are in place before trial initiation. Maintain knowledge of FDA and other global regulations relevant to medical device trials. Site Management: Serve as the primary point of contact for clinical sites. Provide training to site staff on study protocols and data collection systems. Manage and resolve site issues and queries promptly. Support preparation and maintenance of clinical trial documentation such as the Trial Master File (TMF), site binders, and site regulatory documentation. Documentation & Reporting: Maintain TMF documentation in compliance with SOPs. Draft monitoring reports, follow-up letters, and site visit summaries. Assist in the development of study protocols, CRFs, ICFs, and other clinical documents. Cross-functional Collaboration: Work closely with clinical project managers, regulatory affairs, quality assurance, and R&D. Support clinical strategy discussions and device lifecycle planning. What We're Looking For
Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or related field. 3+ years of experience monitoring clinical trials, preferably in the medical device industry, with sponsor-side exposure. Experience working in Neuroscience space. Strong understanding of ISO 14155, FDA 21 CFR Part 812, and ICH-GCP guidelines. Experience with EDC systems (e.g., TrialMaster, REDCap, or similar). Strong attention to detail and ability to manage multiple priorities under pressure. Proficient in Microsoft Office and Teams; familiarity with Google Workspace and Dropbox is a plus. Excellent written and verbal communication skills. Willingness to travel up to 30%. Preferred Qualifications
Master’s degree or advanced clinical/scientific training. Experience with Class II or III medical devices. Certification (e.g., ACRP, SOCRA) is a plus. Salary Range
SF Bay Area/NY Metro/LA Metro: $134,000 - $164,000 per year National: $107,000 - $128,500 per year In Addition to Your Base Compensation
Annual Bonus + Equity Opportunity 100% Employer paid Health Benefits for Employees 100% paid Life and Long-Term Disability Insurance 401(k) with a generous company match Employee Stock Purchase Plan (ESPP) with a discount Monthly cell phone stipend Flexible paid time off 11 Paid Holidays + 5 Company Wellness Days Excellent parental leave policy Fantastic culture with tremendous career advancement opportunities Joining a mission-minded organization
#J-18808-Ljbffr