Senior Clinical Trial Manager

Senior Clinical Trial Manager South San Francisco, California, United States Role Summary Hands-on clinical trial leader responsible for day-to-day execution of mid to late-stage CKD studies. This role partners closely with cross-functional teams and external vendors to ensure studies are delivered on time, within budget, and with high data quality and compliance standards. Core Responsibilities Study Execution Co-lead Phase 2-3 CKD study execution from protocol development through CSR Support key milestones including FPI, enrollment completion, interim analysis, and database lock Lead feasibility assessments and support site selection strategy Develop enrollment forecasts and support KOL engagement with Clinical Science CRO, Vendor & Site Management Lead RFP process and vendor selection for CROs and trial partners Support contract and budget negotiations Provide day-to-day oversight of CROs, vendors, and sites to ensure performance and compliance Budget Oversight Track study budgets and manage vendor spend in partnership with Clinical Operations leadership Quality & Compliance Ensure data integrity and adherence to protocols, SOPs, and ICH-GCP Support inspection readiness efforts with Quality Assurance Operations & Systems Help evaluate and implement clinical systems (eTMF, CTMS, RBM, etc.) Contribute to SOP development and scalable operational processes Cross-Functional Collaboration Partner with CMC and Clinical Supply Chain to manage drug supply logistics Work closely with internal functions to ensure smooth study delivery Qualifications Required Bachelors degree in scientific or health-related field 58 years Clinical Operations experience, including 4+ years as a CTM Hands-on management of Phase IIIII clinical trials Knowledge of FDA, EMA, and ICH-GCP guidelines Experience with clinical systems (e.g., Medidata Rave, Veeva) Experience with study start-up through close-out CRO/vendor oversight and clinical trial budget tracking experience Strong execution and cross-functional coordination skills Comfortable in fast-paced, growth-stage environment Excellent communication skills Willingness to travel up to ~30% Preferred Global trial experience Experience in common disease drug development