扬 杨

Take medical monitor’s role and oversight medical monitors’ work for early phase oncology/hematology studies, and HV Phase I trials. Provide medical input in the protocol, CSR and other clinical trial key documents. Take pharmacovigilance physician’s role to review and provide medical queries to ICSRs, to write narratives for CIOMS and safety sections for DUSR. Experience in people management, SOP development, TA training development and providing.

FIH oncology studies. Take medical monitor/writer, PK/PD expert and study manager's role for different studies.

Study manager/ Medical writer for early phase study（phase I and clinical pharmacology study, oncology, CV）for 5 years ; Clinical auditor for 1 year.

CRA for oncology phase II/III studies.

BE+PK studies,project lead and pharmacologist for 3.5 year, Quality manager for 1 year

Pop PK，DMPK