SR. CLINICAL DATA MANAGER

DUTIES: Create a data management plan (DMP), edit check specifications, data transfer agreements (DTS), an SAE reconciliation plan, and a document with coding conventions & specifications; Conduct User Acceptance Testing (UAT) on Clinical Data Base & provide feedback to the team on programmed listing and edit checks; Lead programmer in the creation of analysis datasets, TLFs (Tables, Listings, and Figures), data and report validation, and study documentation maintenance; Execute SAE and data reconciliation for a number of clinical trials; Experience documenting DM documents in Veeva Vault eTMF, reviewing ALS, eCRF specifications, & aCRF’s while performing EDC initial build and migrations; Ensure that QC & UAT of EDC tools & modules are completed properly, including database testing, data exporting, and programming.