Job Summary
:
Leads all aspects of clinical data management activities from study initiation through database lock and study closeout. Develops, optimizes and controls data management system, including external clinical research centers in compliance with medical device regulations. Oversees and ensure that all CooperVision sponsored clinical trial data are accurate, complete, and compliant.
Generate, contribute, and/or review key study documentation such as data management plans, case report forms (CRFs), database specifications, test plans for user acceptance testing (UAT), and data transfer specification and agreementsLead electronic case report form (eCRF) developments and facilitate cross-functional reviews of eCRF contentSupport the design, development, and validation of clinical trial databases and eCRFs, including edit checks within the Electronic Data Capture (EDC) systemPerform training on the EDC system, dataflow, and quality contro...