Work Schedule Second Shift Afternoons Environmental Conditions Adherence to all Good Manufacturing Practices GMP Safety Standards Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs WPDs to assess the safety and efficacy of investigational products and or medical devices Identifies resolves and updates data discrepancies Makes changes to the data Management database as required Generates tracks and resolves data clarifications and queries May implement CRF design in identified graphic design package Reviews data listings for accuracy and consistency of data Analyzes and resolves data validation and other data management reports Produces project-specific status reports for CDM management and for clients on a regular basis Performs data management activities such as Responsible Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews Works on difficult or complex assignments requiring considerable judgment and initiative to resolve issues Understands implications of work and makes recommendations for solutions and or new procedures As a skilled or highly skilled specialist completes tasks in resourceful and or creative ways and may contribute to the development of concepts and techniques May act independently on determining methods and procedures on new assignments May be a facilitator and or team leader formal or informal Contacts are frequent with individuals representing outside organizations and or individuals of significant importance within the company Contacts involve planning and preparation of communications requiring skill tact persuasion and or negotiation to accomplish the objectives of the communication