Clinical Trials Manager

Role: Clinical Trials Manager overseeing multiple immunotherapy-focused clinical studies in oncology, with a focus on cell and biologic therapies. Responsibilities include developing and managing trial documents, site recruitment, initiation, training, and monitoring, as well as ensuring protocol safety compliance and supporting data collection and reporting. The role involves stakeholder liaison, regulatory document coordination, and leading communication efforts like DSMB and team teleconferences. Requirements: Bachelor's in biological sciences with 5+ years of clinical research experience, proficiency in MS Office, strong communication and organizational skills, and understanding of SOPs. Preferred qualifications include experience in immunotherapy, cell therapy, or oncology trials, especially in early to late-phase development, with familiarity in regulatory and GxP environments. The position involves on-site or remote work with approximately 20% travel, based in Southern California. The role supports a biotechnology company developing immune-system-based cancer therapies, including FDA Breakthrough Therapy-designated products, emphasizing innovative platform technologies, immune response modulation, and potential cancer vaccines.