Shaniqua Archer
Senior Clinical Operations Leader - Super User @精鼎医药
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WORK HISTORY
Senior Clinical Operations Leader - Super User @精鼎医药
US
Act as Subject Matter Expert (SME) for Parexel systems and processes (CTMS, eTMF, SOPs, etc.).Advise global clinical leadership teams in system and process-related questions.Develop and post process guidelines.Develop and lead process training.
EDUCATION
Central Michigan University
MSA, Health Services Management
Walden University
Doctor of Philosophy (Ph.D.), Public Health/Epidemiology
East Carolina University
BS, Child Development
SKILLS
ABOUT SHANIQUA ARCHER
Over 20 years of experience in the clinical research industry in various roles including Global Clinical Operations Leader, Associate Project Manager, Clinical Data Associate, Clinical Data Coordinator/Endpoint Validation Coordinator, on-site Clinical Research Associate, Lead Clinical Research Associate and in-house Senior Clinical Monitoring Associate. Experience in Phase I-IV drugs, vaccines and observational studies, with emphasis on compliance with GCP and ICH Guidelines. Experience with Expanded Access Programs (Compassionate Use Studies) as well as EDC experience with InForm, Clinphone (Datalabs), and Medidata RAVE. Conducted qualification visits (remotely and on-site), initiation visits, monitoring visits, and termination visits. Therapeutic area expertise:Experience in various therapeutic areas including: cardiology, psychiatry, neurology, endocrinology, gastroenterology, dermatology, oncology, respiratory and infectious disease.
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