Direct and supervise all aspects of the data management process, ensuring compliance with FDA regulations related to data management. Provide guidance to Clinical Database Administrator. Train data entry personnel and Clinical Research Associates (CRA) in procedures relative to data management. Ensure compliance with department procedures. Provide input into Case Report Forms (CRF) design and approve CRFs for production use. Oversee the design of Oracle Clinical databases, including maintenance of the global library; validate database design; program edit-check procedures and validate new edit-check processes; perform and direct data entry processes; run batch validation and track DCFs through data cleaning; code adverse events and concomitant medications using standard coding dictionaries (MedDRA, WHO Drug); maintain coding dictionaries; lock/freeze databases; extract into SAS datasets for analysis. Administer Oracle Thesaurus Management System repository. Set up new studies in the Clinical Research Management System (CRMS) clinical trial management system, and maintain the CRMS database. Train new CRAs in the use of CRMS.
Required Experience:
1-2 years Electronic Data Capture (eDC) RAVE build experience - Able to build studies in Medidata RAVE 2. 2-3 years Data Management experience 3. 1-2 years Project Management experience
Keyword: Clinical Data From: Pharmaceutical Associates,LLC
