Junyao He Email & Phone Number

中国 上海 静安区

Shanghai

中国 上海市区

Provide routine data management oversights of CROs, from phase 1 to phase 3. Build up Corporate Data Standard libraries based on CDISC standards for different Oncology indications. Establish Data Management related SOPs & Guidance in terms of Vendor Oversight and internal data management process. Build up internal capabilities to provide end to end DM service in-house, from database set-up to study close out with selected EDC system.

As Certificate Clinical Data Manger (CCDM), proficiency in the entire DM responsibilities and experienced from Study Set-up to Database lock under different data standard and different data management system OC, Datalabs, InForm, etc.As data quality lead (DQL) in study team, involved in all team meeting, decision making, contributing expertise in data quality ensurance. Lead team to focus on essential data, perform instream data review, protocol deviation management, etc. Play as sponsor data management representative to oversee CRO’s DM work. As Data Manager involved in multiple clinical studies in different TAs especially in Oncology, Infectious disease, Immune Inflammation(RA), through Phase I to Phase IV.

Pfizer

As Lead Data Manger (LDM), proficiency in the entire DM responsibilities and experienced from Study Set-up to Database lock under different data standard and different data management system OC, Datalabs, etc.

Mqm, Master Of Quantitative Management

Master'S Degree, Pharmaceutics

Bachelor'S Degree, Pharmaceutics