CoMind
Clinical Project Manager
Remote, US · Senior
Sponsorship not specifiedDetected 49 days ago
GCPData ScienceProject ManagementClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchCommunicationCollaboration
About the role
- 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
- 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
- Develop and maintain clinical project plans, timelines, and budgets; lead site feasibility assessments, selection, and CTA negotiations for assigned studies
- Strong communication, organisational, and documentation skills with the ability to manage multiple studies simultaneously
Requirements
- support internal and external audits and FDA inspections as required
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
Skills
- 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
Compensation
- Annual Unlimited PTO
Benefits
- Company equity plan
- Annual Unlimited PTO
- Health insurance plan
- Dental insurance (50% Employer Contributions to individual policy)
- Vision insurance (50% Employer Contributions to individual policy)
- Mental health resources
Company info
- 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.
This listing is sourced directly from CoMind's careers page and normalized into a canonical job model.