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.