Quality auditor more than two years of experience in the field of clinical trials and BA/BE. Oversee all regulatory aspects of clinical studies starting form protocol review Informed consent, clinical activities, clinical trial site audits, raw data evaluation, conclusion of the study form statistical analysis, and final submitted report to regulatory authority. Working knowledge of Industry standards including ICH, GCP, code of federal regulation, EU standards and other regulatory. Proficiency in developing different clinical study related documents. Comfortable in working with multiple projects. Relies on my basic, experience and technical knowledge.
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