Melanie Purcell Email and Phone Number

-Effectively manage clinical trials acting as team lead and ensuring all key deliverables are met and successfully executed according to study timelines. -Phase I experience in FIH, SAD, MAD, BE, & PK studies-Experience writing study protocols, ICFs, Study Drug Binder, Laboratory Binder, PK & FFA Manual, Monitoring Manual, and Medical Monitoring Oversight Manual-PSSV, SIV,IMV, & COV as well as remote monitoring -Review main & substudy ICF's for Phase III study - Experience managing multiple central lab vendors-Review and process vendor invoices against milestone payments-Run weekly meetings acting as team lead-Working knowledge of GCP and ICH guidelines