Data Science Program Lead II

Role: Clinical Data Strategy and Operations (CDSO) Data Management Lead or Clinical Data Scientist (CDS) serves as the expert and strategic partner in clinical data management, ensuring high-quality, inspection-ready data for clinical trials. Responsibilities: lead data collection, cleaning, and database lock strategies; oversee risk-based data review and centralized monitoring; interpret operational and clinical data to inform study decisions; manage data flow from raw EDC to SDTM, and perform data mining and analytics; ensure compliance with GxP, GCP, ICH guidelines; influence cross-functional teams without direct authority; drive process improvements and mentor team members. Requirements: bachelor’s degree in life sciences, management information systems, or related fields; 6+ years experience in pharma, clinical research, data management, or 8+ years in project management; deep understanding of clinical trial processes and technology; demonstrated leadership, influence, and communication skills. High-Value: expertise in clinical data management for trials, with emphasis on data quality, regulatory compliance, and process optimization; experience across phases of clinical development (IND, Ph1-3); familiarity with EDC, SDTM, data analytics, and risk-based monitoring; cross-functional stakeholder engagement. WorkSetup: not specified; travel requirements not mentioned.