Senior Manager, Clinical Operations

Role: Senior Manager, Clinical Operations overseeing Phase 1–3 trials in a rare disease biopharma setting. Objectives include managing trial execution, timelines, budgets, and vendor relationships to ensure successful clinical study delivery. Responsibilities encompass supervising internal teams, CROs, and vendors; resolving study issues; coordinating cross-functional activities including biometrics and PV; and developing study documentation. The role involves strategic input, tracking study metrics, and managing trial materials. Qualifications: Bachelor's degree or equivalent; 7+ years of clinical trial experience with at least 2 years managing studies at sponsor or CRO; knowledge of global regulatory standards (US CFR, EU CTD, ICH GCP); and experience with Phase 1–3 studies, including international trials preferred. Key skills include proactive leadership, problem-solving, excellent communication, and proficiency in MS Office, project management tools, and clinical systems like IRT or eTMF. Travel of 10–20% domestically and internationally is expected. High-value specifics: focus on rare diseases, Phase 1–3 clinical development, sponsor/CRO management, and global regulatory compliance. Work setup involves onsite presence in San Diego with some remote flexibility.