Experienced clinical data and Systems professional with over 20 years in Bio-pharmaceutical and health care industries. Expertise in establishing statistical reporting department using SAS, electronic submissions (eCTD) ,selection and implementation of regulated clinical systems, clinical data bases and management, regulatory electronic submissions, data management, technology planning and management, Interactive Voice Response System (IVRS), randomization administration, Web based electronic data capture, resource allocation methodology, FDA’s 21 CFR part 11, GCP, and strategy, WEB page and Intranet technology. Specialties Statistical Programming, Technology selection and implementation, Data quality and standardization, Regulatory electronic submissions, Data and systems validation, Implementation of clinical databases, electronic data capture.