Senior Lead Data Manager

• May 2021 - Present

Clinical Data Manager

• Nov 2017 - May 2021

• Responsible for data management operations including data management plan development and maintenance, CRF design, eCRF completion guidelines, database design, database build, database validation and user acceptance testing, data review and discrepancy management, data quality control, data coding, software requirements, SOP updates and data trends communication. • Manage systems integration with EDC, IxRS, reading centers and central labs. • Collaborate with biostatisticians and programmers in the creation of analysis datasets and conformance to the CDASH and CDISC Standards. Show less

Manager Clinical Data Management

• Apr 2015 - Nov 2017

• Head of Clinical Data Management department • Developed/approved clinical study data management related documents • Ensured all clinical data management activities are compliant with SOPs, CRF 21 Part 11, ICH GCP, and Good Clinical Data Management Practice by Society for Clinical Data Management (SCDM) • Hands on in study protocol review and approval process, as well as other Clinical Operation related documents: Safety Management Plan, Study Monitoring Plan, etc. • Designed study databases, supervised and approved database build and implementation, including but not limited to, data specification, edit checks, UAT and system deployment • Oversaw all data management activities, such as discrepancy management, SAE reconciliation, data cleaning, Medical Monitor review, data coding, database set up and lock • Collaborated with multiple international CROs, Statisticians, PVG, Medical Director, Study Project Managers and DBAs to ensure all deliverables are met within each established timeline • Line-management to delegate responsibilities to CRO team and Sponsor Data Management team • Responsible for data management related vendor selection, budget review, contract review and approval • Identified and evaluated site, CRO, and vendor’s performance gap and worked with them to strategize resolution plans • Reported directly to Director of Biostatistician and VP of Clinical Operation • Provided professional guidance to team members not limited to DM functional area Show less

Associate Clinical Data Manager / DBA

• Sep 2011 - Mar 2015

• Developed study Data Management Plan and SOPs• Project lead for CDMS system validation, CRF/database design and implementation, including data specification, edit checks and study database validation• Oversaw internal study data audit and study close out in calibration with study team, CRO, statistician and data programmer• Managed EDC system and implemented QA process at each stage in data handling to assure data are reliable and processed correctly• Provided data discrepancy management for both paper based and EDC trials • Monitored all activities in database, such as, data entry/change, AE notification and eCRF status• Wrote mid-study updates, including writing risk management, validation plan and testing scripts• Performed AE reconciliation• Initiated all training documents needed and provided CTMS and EDC system training to study team, CROs and study sites personnel • Implemented training program to study team in regards of data management• Supervised outsourced data management activities Show less

Clinical Data Associate

• Mar 2011 - Sep 2011

• Performed data entry on EDC systems• Handled data discrepancy management• Provided analytical reports to Clinical Data Manager and Study Managers• Monitored all activities in database, such as data entry/change, AE notification and eCRF status• Performed CRF and database design • Provided EDC system training to the study team, CROs and study sites personnel

Consultant/Recruiter

• Jan 2003 - Dec 2008

• Consultant for multiple US companies, such as Toro, to achieve China Compulsory Certification (CCC) in order to export their products to China for commercial use. • Propose business solution • Price negotiation • Manufacture inspection on behave of clinets • Recruiting college graduates and teachers who were interested in teaching abroad for multiple language learning centers in Beijing, Shanghai and Shenyang. Review and qualify resumes for requested positons • Hosting small recruitment event or participating in college job affair. • Manage clients relationship • Translate documentation and provide interpreter services. Show less

General Manager

• May 1999 - Jun 2000

• Business decision approval • Contract negotiation and public relations • Senior management hiring • Supervision of all business activities • Business decision approval • Contract negotiation and public relations • Senior management hiring • Supervision of all business activities

Web Designer/Coordinator Data Management

• Dec 1997 - May 1999

•Design web pages for online education website using FrontPage. •Collect, validate and derive data from online education data base in order to assist program engineers to develop better learning tools for students. •Design web pages for online education website using FrontPage. •Collect, validate and derive data from online education data base in order to assist program engineers to develop better learning tools for students.