Drug Safety Specialist

Description

Works with Lead Data Manager to test, analyze, and document databases, user testing, and system and study specs. Performs Clinical Data Management (CDM) review of all study subject information captured during the conduct of a clinical study. Works on a project team and complies with all Standard Operating Procedures (SOPs)/ Work Instructions (WIs), regulatory guidelines and directives, and study specific plans pertaining to collection, review and management of clinical study data. Creates test data, and validation guidelines Design case report forms and generation of DCFs Collaborates with Clinical to finalize CRF design Annotates CRFs properly May be required to design user interface using optical character recognition or webbased electronic data capture technology (EDC) Collaborate to establish the clinical database setup Develops, implements and maintains Data Prep Plan with input from Medical, Clinical and RDO Reviews CRFs for data issues and inconsistencies Interacts regularly with study team regarding CRF review and completion procedures May be required to code and/or maintain coding dictionaries for adverse events and/or medications, such as MEDdra and WHODRN Must ensure that databases meet requirements of clinical projects. Requires knowledge and understanding of the data management process to facilitate timely data review and processing.