Clinical Operations Manager

Role: Senior Clinical Operations Lead overseeing global clinical trials from first-in-human to Phase 3, with a focus on rare diseases and gene therapy modalities. Responsibilities: manage study planning, vendor oversight, trial execution, and compliance; contribute to protocol development, risk mitigation, site evaluation, patient recruitment strategies, and study data review; oversee budgets, drug supply, and study close-out activities; ensure inspection readiness and regulatory compliance. Requirements: Bachelor’s in a relevant scientific or healthcare discipline; 8+ years in clinical operations, including 4+ years as trial manager; strong knowledge of ICH/GCP, regulatory guidelines, and trial management systems; experience with FDA/regulatory inspections preferred. High-Value: rare disease, gene therapy, global clinical trials, regulatory compliance, cross-functional leadership in a fast-paced environment. WorkSetup: unspecified; travel requirements not detailed.