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As the drug development business of Laboratory Corporation of America Holdings (Labcorp) and the world’s most comprehensive drug development #CRO service company, we have helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. Because of our broad experience and specialized expertise, we&rs...
About the job
Job Overview
External Data Reviewer
Get ahead in your career and make a difference in people's lives!
Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others? Are you looking to progress your career within Data Management?
If you are looking for a high-energy position in a collaborative environment, learn more about the External Data Reviewer opportunity with Labcorp.
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
Education/Qualifications
Medical Laboratory Technology certificate preferred
Associates or Bachelor’s degree or relevant experience
Experience
Minimum 0-3 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job, involving data management or laboratory/trials experience.
Knowledge of CRF would be advantageous
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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