Sr. Clinical Research Associate/Clinical Trial Manager

Role: Senior Clinical Research Associate/Clinical Trial Manager supporting clinical operations for early-phase biopharma studies, primarily remote with quarterly visits to San Francisco. Responsibilities: oversee study conduct from planning to close-out, manage regional site performance, vendor relationships (CROs, labs, imaging), ensure GCP compliance, review monitoring reports, maintain study documentation, and support regulatory filing efforts. Requirements: Bachelor's degree or equivalent (RN/PA/BSN), 4-6+ years of clinical trial experience supporting global studies, vendor management, and site monitoring. Preferred: biotech/pharma sponsor experience, knowledge of ICH GCP R3, TMF oversight, proficiency in MS Office and SmartSheet. High-Value: supporting early-stage (Phase 1-2) clinical trials in rare diseases, with emphasis on quality oversight, vendor relationships, and remote collaboration. Travel: up to 20%.