Shawna Barker
Director, Data Quality Project Manager @Institute for Neurodegenerative Disorders
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WORK HISTORY
Director, Data Quality Project Manager @Institute for Neurodegenerative Disorders
EDUCATION
Southern Connecticut State University
Bachelor of Science (BS), Applied Mathematics
SKILLS
ABOUT SHAWNA BARKER
7 years of experience in Data Management, Project/Program Management, and System Validation roles to support GxP system development and pre-clinical and Phase clinical imaging trials in a regulated environment. Proficient in industry regulations and standards (21 CFR Part 11, Annex 11, GAMP5, ICH E6, ICH Q9, ICH Q10, CDISC SDTM). Extensive experience writing test protocols (IQ, OQ, PQ, UAT) as well as compliant high level policies/procedures and technical documentation.
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