Senior 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. Skills- SAE, UAT, Veeva Vault & EDC tools. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. 

REQUIREMENTS: Master’s degree in Health Care Informatics, Health Administration with 1 year of experience a job title with similar duties and skills.