Clinical Data Manager II

The Clinical Data Manager II is an experienced professional with extensive knowledge on end-to-end data management activities in various clinical studies and phases. They manage the day-to-day activities of data management with Clinical Research Associates, including subject safety/confidentiality data and critical efficacy endpoints. The role involves configuration and hands-on work with Electronic Data Capture (EDC) systems like Medrio, as well as defining Case Report Form (CRF) requirements. This position also entails developing Clinical Data Management technology, process Quality SOPs, templates, and tools. The Manager will mentor and assist with the onboarding of Clinical Data Managers, ensure all Data Management procedures are executed with high attention to detail, and work with cross-functional teams to ensure accurate and efficient data collection. They are a liaison between Clinical Project Managers and Biostatisticians, supporting EDC system selection and submissions. This role requires in-depth knowledge of Data Management Practices and regulatory guidelines.