Position Overview
Responsibilities:
Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc. Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, ...