This job is based remotely in the US, but you should be based in an Eastern or Central Time zone.The RoleThe Clinical Team leads the deployment of CoMind's technology into hospital environments for the first time, managing clinical sites, supporting device installations, and ensuring the smooth execution of clinical studies in partnership with clinicians.
As Clinical Project Manager, you will own the planning, execution, and oversight of assigned clinical studies, working cross-functionally with clinical operations, regulatory, data science, and investigator sites to ensure studies are delivered on time, within budget, and in full compliance with applicable regulations.
Please note that this role will require approximately 20% travel, depending on study needs.Responsibilities:- Develop and maintain clinical project plans, timelines, and budgets; lead site feasibility assessments, selection, and CTA negotiations for assigned studies
- Prepare and review key study documents including protocols, ICFs, CRFs, and study manuals in accordance with ISO 14155, FDA/ICH guidelines, and CoMind SOPs
- Oversee site initiation, monitoring, and close-out visits, ensuring protocol adherence and data quality; track enrollment and KPIs and proactively mitigate risks to study timelines
- Review monitoring reports and drive timely resolution of site issues, deviations, and CAPA activities
- Manage clinical data activities including CRF completion, query resolution, and data cleaning in collaboration with data management
- Ensure study conduct compliance with 21 CFR Parts 812, 50/56, ISO 14155, and GCP; support internal and external audits and FDA inspections as required
- Author and review clinical study reports, periodic safety reports, and clinical evaluation reports; provide regular study status updates to senior management and cross-functional stakeholders
- AI is fundamental to our culture -- it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively.
Skills & Experience:- 3-6 years of clinical research experience, with at least 2 years in medical device clinical trials
- Demonstrated knowledge of FDA regulations (21 CFR 812), ISO 14155, and GCP guidelines
- Hands-on experience managing clinical sites and/or CRO relationships
- Proficiency with EDC, eTMF, CTMS, and standard office software
- Strong communication, organisational, and documentation skills with the ability to manage multiple studies simultaneously
Nice to have:- Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings
- Experience authoring or contributing to clinical study reports or clinical evaluation reports
Benefits:- Company equity plan
- Annual Unlimited PTO
- Health insurance plan - CoMind contributes 50% to the monthly premium (with the Blue Cross Network)
- Dental insurance (50% Employer Contributions to individual policy)
- Vision insurance (50% Employer Contributions to individual policy)
- 401k plan with an employer match up to 3%
- Mental health resources
