Senior Clinical Trial Manager

Senior Clinical Trial ManagerSouth San Francisco, California, United StatesRole SummaryHands-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 ResponsibilitiesStudy ExecutionCo-lead Phase 2-3 CKD study execution from protocol development through CSRSupport key milestones including FPI, enrollment completion, interim analysis, and database lockLead feasibility assessments and support site selection strategyDevelop enrollment forecasts and support KOL engagement with Clinical ScienceCRO, Vendor & Site ManagementLead RFP process and vendor selection for CROs and trial partnersSupport contract and budget negotiationsProvide day-to-day oversight of CROs, vendors, and sites to ensure performance and complianceBudget OversightTrack study budgets and manage vendor spend in partnership with Clinical Operations leadershipQuality & ComplianceEnsure data integrity and adherence to protocols, SOPs, and ICH-GCPSupport inspection readiness efforts with Quality AssuranceOperations & SystemsHelp evaluate and implement clinical systems (eTMF, CTMS, RBM, etc.)Contribute to SOP development and scalable operational processesCross-Functional CollaborationPartner with CMC and Clinical Supply Chain to manage drug supply logisticsWork closely with internal functions to ensure smooth study deliveryQualificationsRequiredBachelors degree in scientific or health-related field5–8 years Clinical Operations experience, including 4+ years as a CTMHands-on management of Phase II–III clinical trialsKnowledge of FDA, EMA, and ICH-GCP guidelinesExperience with clinical systems (e.g., Medidata Rave, Veeva)Experience with study start-up through close-outCRO/vendor oversight and clinical trial budget tracking experienceStrong execution and cross-functional coordination skillsComfortable in fast-paced, growth-stage environmentExcellent communication skillsWillingness to travel up to ~30%PreferredGlobal trial experienceExperience in common disease drug development