Description
Professional Summary Over 11 years' experience in the Pharmaceutical Industry, focusing on Drug Safety, Regulatory Compliance, Clinical Trials, Protocol Initiation and Management, Data Standards and Maintenance, Study Management, Pharmaceutical Operations, and Basic Molecular Biology Techniques Core Qualifications * Knowledge of GCP's, ICH and FDA Guidelines * Project Development * Knowledge RECIST & CHESON criteria * Safety Data Review & Management * Organizing study startup & conduct activities