Clinical Data Manager

Job Description: Execute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPs Support and contribute to the oversight of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalation Perform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and database lock activities Conduct ongoing data review, cleaning, query management, and quality control to ensure data accuracy, consistency, and completeness Develop, review, and maintain Data Management deliverables, including: Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications Monitor study status metrics and provide regular data management status updates to study teams and functional leadership Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities Identify operational risks, trends, and data quality issues using metrics, audits, and study insights, and partner with teams to implement corrective actions Support inspection readiness activities, audits, and regulatory inquiries related to clinical data management Requirements: Bachelor's degree in a scientific, health-related, or quantitative discipline required Minimum 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry At least 2 years in a Clinical Data Manager role Oncology experience preferred Strong working knowledge of clinical data management processes and regulatory requirements (ICH, GCP) Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes Strong organizational skills with ability to manage multiple priorities in a fast-paced environment Ability to analyze data trends and operational risks to inform decision-making Effective verbal and written communication skills High attention to detail and problem-solving skills Benefits: Merit-based salary increases Short incentive plan participation Eligibility for 401(k) plan Medical insurance Dental insurance Vision insurance Life insurance Disability insurance Paid time off policy includes flexible paid time off 11 paid holidays plus additional time off for shut down during last week of December 80 hours of paid sick time upon hire and each year thereafter