Manager, Quality Assurance, Clinical Trials - Pleasanton, CA
6 days ago

Job summary
In addition to the responsibilities listed below, this position is also responsible for overseeing quality assurance monitoring to ensure compliance in clinical trials addressing monitoring requests identifying deviations/violations of protocol recommending remedies managing the consultation of study workflows to improve compliance outcomes leading auditing activities managing the education of others on regulations Good Clinical Practice Food and Drug Administration regulations HIPAA to ensure compliance training team to support and implement quality management system initiatives including compliance quality control guiding team members to collaborate with internal and external audit agencies during auditing process leading the development and implementation of internal and external audit protocols reviewing analyses of monitoring analysis results managing initial and ongoing study risk assessments reviewing auditing and quality summaries reports.
Job description
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