Senior Clinical Trial Manager (Sr CTM)

Role: Senior Clinical Trial Manager responsible for developing and optimizing clinical operations processes, SOPs, and ensuring high-quality execution of Corcept's clinical studies. Responsibilities include authoring and updating SOPs aligned with ICH-GCP standards, managing cross-functional study activities, vendor and CRO oversight, and regulatory documentation for hypercortisolism, oncology, ALS, and liver disease trials. Key focus on process scalability, inspection-readiness, and continuous improvement, with direct study management for timelines and budgets. Qualifications: BS/BA or nursing degree; 8+ years in biotech/pharma leading clinical activities; experience managing CRO/vendor relationships; strong knowledge of GCP/ICH regulations; proficiency in clinical trial processes and Microsoft Office. Preferred skills include understanding of regulatory submissions and medical terminology. High-Value: Experience in biologics or small molecules within late-stage development (Phases 2-3), with exposure to regulatory filings and multi-center trial coordination. Work Setup: Hybrid (3 days onsite); no travel specified.