Clinical Trial Manager/Senior Clinical Trial Manager

Role: Senior/Clinical Trial Manager overseeing operational execution of autoimmune clinical trials from start-up to close-out. Responsibilities: manage CROs, vendors, sites; ensure regulatory compliance, GCP adherence, and timely delivery; handle documentation, audits, and study metrics; support trial set-up, regulatory submissions, and close-out activities; collaborate with internal stakeholders and external partners. Requirements: Bachelor’s degree with 5+ years (CTM) or 8+ years (Sr. CTM) in clinical trials, preferably in biotech/pharma; experience in complex autoimmune studies; strong knowledge of ICH/GCP, electronic systems (eTMF, CTMS, EDC); independent work ethic, problem-solving skills, effective communicator. High-Value: autoimmune indications, clinical trial phases supporting preclinical/IND/Ph1-3 development, GCP compliance, CRO management, study documentation, and trial setup. Work setup: hybrid in San Diego with remote option upon approval; travel up to 25%.