JobMesh

Senior Clinical Data Manager

Cytel · GB

The Senior Clinical Data Manager will provide comprehensive data management support for assigned clinical studies. The SCDM will be responsible for performin...

Job description

The Senior Clinical Data Manager will provide comprehensive data management support for assigned clinical studies. The SCDM will be responsible for performing ongoing data review to ensure accuracy, completeness, and consistency of clinical trial data in accordance with the study protocol and data management plan. The CDM will have a minimum of four years of clinical data management experience, including hands-on data review experience, and demonstrated proficiency in Medidata Rave. Responsibilities: Clinical Data Management: - Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency. - Identify, investigate, and resolve data discrepancies through query management. - Conduct manual and system-driven data reviews in accordance with study protocols and DMPs. - Collaborate with cross-functional teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to support data cleaning activities. - Participate in database lock activities and ensure data readiness for interim and final analyses. - Maintain study documentation in compliance with regulatory requirements and internal SOPs. - Manage and maintain user access within clinical da...