Data Management External Data Specialist (EDS) - II

Job Overview:

Covance is seeking candidates for a Data Management External Data Specialist (EDS) - II. The Data Management EDS - II can be remotely (home-based) anywhere within the United States. 

 Responsible for review, maintenance and update of External Vendor data received from central vendor or local laboratories. Working to ensure departmental SOPs, guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects. Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly. Develop the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers. Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues. Perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes. Assist with Development and testing of study specific edit checks used for Local lab data review and External vendor reconciliation. Assist with review of laboratory edit checks, laboratory status reports and laboratory listings. Work with Clinical staff to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges and maintain proper documentation. Edit and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module. Responsible as contact person for the External source of electronic data transmissions. Communicate to vendors and client problems involving data transfers, data point issues and validation issues. Assist with training new team members. Perform other duties as required by the Department.   Education/Qualifications:Minimum Required: Medical Laboratory Technology certificate preferred. Associates or Bachelor’s degree or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.  Experience:Minimum Required: 4 - 6 years of experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Ability to maintain confidentiality of data and information during interactions with staff at all levels. Demonstrated computer literacy. Accurate keyboarding skills. Basic understanding of medical terminology. Understanding of ICH-GCP principles. Demonstrates ability to provide training for EDS levels 1 and 2. Ability to manage EDS team for larger client projects.  Local laboratory experience preferred.

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