Description
Skilled in the planning and implementation of clinical research projects in compliance with ICH-GCP, Regulatory Agencies, and company SOP. Study Start up expert. Proficient in Microsoft Office Applications, CTMS, IVRS/IWRS, INFORM, Medidata Rave. Therapeutic areas: Oncology, Cardiology, Neuroscience, Internal Medicine, including Diabetes. Participated in 3 FDA Submissions, FDA Inspection Readiness and TMF reconciliation
