Experienced Clinical Operations and Clinical Data Management professional with over 20 yrs of Biotech/ Pharma industry, and Study Site experience. Phase I through Phase IV clinical studies experience in various therapeutic areas, e.g. infectious disease, oncology, GI, and HIV AIDS.
Evaluated and managed CROs for both Clinical and CDM activities. Monitored and co-monitored national and international study sites (India and Thailand). Led implementation of, and worked with various software systems like DataFax, Oracle Clinical, ClinTrial, Clinical Trial Management system, and Document Management. Experienced in managing clinical trial process from inception to reporting and submission.
Specialties: Management of CROs, study sites (US, Asia), and Clinical Data Management. Establishing Data Management Dept and implementing software systems and processes that are well integrated with Clinical, Biostat/Programming, QA/QC, and Research.