Clinical Data Manager

Job Title: Clinical Data Manager Duration: 9 months Location: Durham, NC 27709 Job Summary The Clinical Data Manager will apply knowledge of Clinical Research, therapeutic areas and Clinical database management to collect, review and analyze clinical data, and to identify and report trends. Supervisory Responsibilities: Provide oversight and QC the CDM deliverables of tasks outsourced to CROs. Duties / Responsibilities Perform User Access Management in Veeva vault EDC, create specifications for data review listings, custom listings in Veeva vault CDB. Perform User acceptance testing in Veeva EDC and CDB, document findings in electronic logs and work with the study team members and vendors to resolve the issues. Design and validate CRFs, clinical databases including designing or testing logic checks. Develop project-specific eCCG, data management plans that address areas such as data coding, reporting, or transfer, database locks, and work‑flow processes. Generate data queries based on validation checks or errors and omissions identified during data review to resolve identified problems. Design DTS for receiving, processing, or tracking data. Process clinical data transfers including receipt, entry, verification, or filing of information. Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data. Monitor work productivity or quality to ensure compliance with standard operating procedures. Perform other related duties as assigned. Required Skills/Abilities: Excellent knowledge of computers and EDC systems, and administration and management skills. Veeva vault EDC, CDB experience. Education and Experience: Bachelor's degree in management information systems or other computer‑related, science‑related fields required or equivalent experience. Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 10 pounds at times. #J-18808-Ljbffr