Chih Hsuan Chen

About Chih Hsuan Chen

English/]Master degree in Knowledge Engineering from National University of Singapore, focusing on Machine Learning and Data Science. Fluently in English, Chinese Mandarin (Native), and Japanese(N2): Over 10 years experience as clinical database programmer in CRO/Pharm.(Medidata RAVE, ORACLE Clinical One)Run through all the clinical database life cycle across clinical trial phases from EP to LP(Phase I to IV). Completed several multi-center worldwide projects with some of the top pharmaceutical companies (Japan/Korea/US/EU). Collaborated with multi-cultural team and cross-functional departments between different countries and regions./CRO10RaveeCRFEdit CheckCustom FunctionDB

Experience

1. Senior Clinical Database Administrator

   QPS Holdings, LLC

   Jul 2022 — Present · Taipei City, TW

   Design and Setup Global Library in RAVE/Clinical One based on CDISC/CDASH standard: •Following the ICH-GCP standard to design and create the global library CRF template with Data Managers(DM) and Biostatistics(BS) team. •Setup the global library in Rave EDC based on the CDISC/CDASHIG/SDTMIG standard naming conventions. •Create the data validation specsification for derivations and dynamics in global library. •Setup the Real-Time edit checks based on the data validation specsification for global library. •Implementing TQC/UAT processes and roll out the global library by batch volumns.Medidata Rave EDC Setup: •Following SOP to develop Rave EDC based on protocol and CRF documents. Including CRF setup, Edit Check programming, QC for both CRF and Edit Checks setup. •Support UAT activity with Data Managers and Data Validation Plan setup, setup custom functions(CF) programs for derivations and dynamics in eCRF. •New URL setup and configuration for sponsors, including all accounts, roles, permissions configuration. Other post go-live operational tasks, access control, reports administration, MEDS report setup.Oracle life science Clinical One Setup: •Following SOP to develop Clinical One based on protocol and CRF Excel standard. Including CRF design, custom rules programming, TQC for both CRF and custom rules. •Support UAT activity with Data Managers and Data Validation Plan setup, setup custom rules and validation rules for derivations/calculations and dynamics within the eCRF. •New URL setup and user administration for the study, including all suer accounts, study roles, and rule permissions setup. Other post go-live operational tasks including applied chanages of the sites.

Education

• SHINJUKU Japanese Institute - SNG

  Japanese , Japanese Language and Literature

  2006 — 2007

• National University of Singapore

  Master of Technology (M.Tech.), Singapore MOE Scholarship Subsidy , Knowledge Engineering

  2013 — 2014

• San José State University

  Taiwan MOE Scholarship , Information Technology

  2008 — 2009

• Tatung University

  Bachelor of Business Administration (BBA), Management Information Systems

  2006 — 2010