ClinicalProjectManager

This job is based remotely in the US, but you should be based in an Eastern or Central Time zone. At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world. The Role The 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 inspect