Job Description: Clinical Database Programmer with extensive data management experience in designing Oracle & Medidata Rave Clinical databases, creating Oracle Clinical validations, derivations and SAS views and 2 years of experience in Clinical Data Management as a Clinical Data Manager/ Analyst with expertise in designing Data specifications document, Edit Check Specifications, User acceptance Testing, External data Specifications, Data transfer specifications Recognized for improving data review efficiency through proficient use of SQL and PL/SQL. Has extensive understanding of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer system. Overall knowledge on Discrepancy Management and communicating with team including External data reconciliation, SAE data checking. Ensures clinical data within EDC is in quality to freeze and lock as appropriate for interim and statistical review Experience with team
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