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Second Shift (Afternoons)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
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 medicaldevices. Identifies resolves and updates data discrepancies. Makes changes to the datamanagement database as tracks and resolves data clarifications and queries. May implementCRF design in identified graphic design data listings for accuracy and consistency of data. Analyzes andresolves data validation and other data management project-specific status reports for CDM management and for clients ona regular data management activities such as Serious Adverse Event and ThirdParty Vendor reconciliations as well as Data Listing on difficult or complex assignments requiring considerable judgment and initiative to resolve issues. Understands implications of work and makesrecommendations for solutions and / or new procedures. As a skilled or highly skilled specialist completes tasks in resourceful and / orcreative ways and may contribute to the development of concepts and techniques. May act independently on determining methods and procedures on newassignments. May be a facilitator and / or team leader (formal or informal).Contacts are frequent with individuals representing outside organizations and / orindividuals of significant importance within the company. Contacts involve planningand preparation of communications requiring skill tact persuasion and / ornegotiation to accomplish the objectives of the communication.
Required Experience:
IC
Full-Time