Occupation:Clinical Data Management |
Location:Mankato, MN |
Education Level:Master |
Will Relocate:YES |
Description
SUMMARY * 5.4 years of experience in analyzing and gathering data for Clinical trials. * Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data-management lifecycle. * Work closely with Oracle Clinical developers on the design, testing and implementation of study databases. * Extensive experience in trial start-up, trial conduct, database lock and Post database lock activities. * Also skills in EDC systems, well-versed in clinical GCP and FDA standards and regulations, and knowledgeable in therapeutic indications. * Collaborate with the Clinical Project Managers (CPMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock. * Perform Data Validation ensuring completeness and clean data. * Completed Diploma in Clinical Research and Clinical Data Management 2011 - 2012 from Jain University, Bangalore. * Completed Master of Science in Biochemistry and Bachelor of Science in Biotechnology. * A fast learner and good at reproducing and applying techniques. * Excellent skills in problem solving, coordination and analysis.
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