Senior Clinical Data Manager

Summary The Senior Manager, Clinical Data Management serves as the Data Management lead for assigned clinical trials and is responsible for the planning, oversight, execution, and delivery of data management activities from study startup through database lock and study closeout. The role provides sponsor oversight of outsourced data management activities, ensures high-quality and inspection-ready clinical data, and collaborates with cross-functional stakeholders to support trial execution, regulatory compliance, and clinical development objectives. Your Role: Serve as the Data Management representative within the Clinical Trial Team (CTT) and provide oversight of Data Management activities throughout the clinical trial lifecycle Provide sponsor oversight of CRO and external data vendors, ensuring Data Management, IRT and eCOA activities and deliverables are executed in accordance with study requirements, quality standards, timelines, budgets, contractual obligations, and regulatory requirements Ensure timely delivery of complete, accurate, reliable, and inspection-ready clinical data through effective oversight of outsourced Data Management activities, including EDC, IRT and eCOA system build, validation and maintenance, data collection, data cleaning, medical coding, external data integration and reconciliation, database/system lock, and submission readiness Review and approve key Data Management deliverables, including CRF/eCRF, IRT, eCOA specifications, edit checks, Data Management Plans, CRF completion guidelines, data transfer specifications, external data reconciliation plans, and other study-specific documentation Establish and monitor data quality metrics, KPIs, and data review strategies to ensure data integrity, consistency, and compliance throughout the study lifecycle Lead oversight of external data integrations, transfers, reconciliations, and vendor-managed data streams to ensure completeness, quality, and regulatory compliance Partner with CTT, CRO and external vendors to support effective planning, integration, review, and reporting of clinical trial data Identify data-related risks and issues and lead the development, implementation, and monitoring of mitigation and contingency plans Participate in audits, inspections, and inspection readiness activities and ensure timely assessment, response, and resolution of Data Management-related findings Contribute to regulatory submissions, health authority responses, and other regulatory deliverables, as required Support the development and implementation of Data Management standards, processes, technologies, and continuous improvement initiatives What You Bring: Bachelor's degree in Computer Science, Life Sciences, Mathematics, Health Sciences, or related field 5+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO industry Experience leading Data Management activities for clinical trials in a regulated environment Experience managing outsourced Data Management activities and providing vendor oversight Experience managing clinical systems (incl. IRT/ eCOA) configurations and implementations, enhancements, integrations, and technology vendors; Experience leading User Acceptance Testing (UAT) Experience supporting database build, data cleaning, external data integrations, medical coding, database lock, and submission readiness activities Experience working within global clinical development organizations Experience supporting audits, inspections, and inspection-readiness activities preferred Experience using electronic data capture (EDC) platforms and clinical data technologies Oncology clinical development experience preferred Strong knowledge of Clinical Data Management processes and the clinical trial data lifecycle Strong knowledge of ICH-GCP, FDA regulations, EU Clinical Trial Regulation (CTR), data integrity principles, and other applicable regulatory requirements Knowledge of CDISC standards, including CDASH and SDTM, and associated clinical data requirements Proficiency with EDC systems, IRT, eCOA, and related clinical technologies Knowledge of medical coding dictionaries, including MedDRA and WHODrug Familiarity with data visualization, analytics, and reporting tools Strong understanding of risk-based quality management and critical-to-quality (CtQ) principles Strong vendor management and sponsor oversight capabilities Strong project management, organizational, and prioritization skills Excellent collaboration skills with cross-functional stakeholders, including Biostatistics, Statistical Programming, Pharmacovigilance, Clinical Operations, and Regulatory Affairs Strong analytical thinking, problem-solving, and decision-making capabilities Excellent written and verbal communication skills #LI-Hybrid We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Salary range $144,800 - $217,200 USD #J-18808-Ljbffr