Covance by Labcorp is recruiting an External Data Reviewer in Kiev.
- Ensure electronic vendor data contains all protocol-specified parameters, is in correct format and data populates to the specified fields and patients correctly.
- Assist in the development of 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 the total number of patients in the study for loading purposes.
- Assist with review of External Data edit checks, External Data status reports, and External Data listings.
- Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges, and maintain proper documentation.
- Enter 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 of the database.
- Responsible as a contact person for the External source of electronic data transmissions with initial oversight for support of this communication from EDS 2 or 3 levels.
- Communicate to vendors and client problems involving data transfers, data point issues and validation issues.
- Perform other duties as required by the Department
- Medical Laboratory Technology certificate preferred
- Associates or Bachelor's degree or relevant experienceExperience:
- Minimum 0-3 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Ability to maintain the 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
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