Experience

Genor BioPharma Co., Ltd.

• China
• Biotechnology Research
• 1 - 100 Employee

• Associate Director

  • Feb 2019 - Present



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• DTL

  • Sep 2016 - Jan 2019

  1. 9+ years DM experience in multinational pharmaceutical companies and CRO, 5 years as a CDM project lead. 2. 2.5 years Database design experience. (Have SDBE international recognized certification), more than 30 study database go live or database change, including 20 oncology studies.3. Well control DM service budget, well familiar with change order skills.4. Lead 10 team members in the past 2 years, utilization, efficiency evaluation, deliverables quality assessment; collaboration, engagement and motivation.5. Gaijin serves as Data Team Lead with strong experience in multiple therapeutic areas, including oncology, immunology, cardiovascular and infectious diseases.6. Have strong experience in Rave and Inform platform.



Covance Clinical Research Unit, Inc.

• United States
• 1 - 100 Employee

• Lead programmer in Database Design

  • Jan 2014 - Sep 2016

  Lead programmer in Database Design, Initial set up more than 20 studies and change database for 15 studies, served Top 5 Pharmas and local Pharmas. Lead programmer in Database Design, Initial set up more than 20 studies and change database for 15 studies, served Top 5 Pharmas and local Pharmas.



Covance Clinical Development Services, Beijing, China

• CDC-2

  • Jan 2012 - Jan 2014

  • Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.• Writing database specifications• Designing or assisting in the design of Case Report Forms or other data collection tools• Programming edit checks• Performing testing and validation of system functionalities• Designing and generating data reports using report tools, eg. J-review, etc.• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities• Ensuring quality and accuracy of research data• Reporting on study timelines and deliverables• Achiving TMF and achieving Audit requirements• Communicates effectively with study teams and departmental associates. Establishes support and collaborates with others both inside and outside the company• Anticipates problems, issues, and delays, and proactively works to minimize the impact• Perform other duties as assigned by manager.



MSD, Beijing, China

• ADC

  • Oct 2010 - Dec 2011

  • Perform good data management for responsible trial, eg, MK974-065; MK822-031; V710-003; MK822-018；MK3102-006; MK0000-139; V501-015; MK8342A-P06450• Keep good matrix: Query answered to query closed cycle time median of 1 day; Visit to data review performed cycle time median of 5 days; LDA to DBL cycle time of 10 days average• Ensure good data quality: Data review process quality of 0.45 errors per 1000; Maintain zero serious quality transgression critical audit findings from regulatory inspection• Assist CTS study, eg, Archive MK822-004; V520-018; MK524-024.• Support data entry: NR: V212-001, MK4827-014, MK646-027, MK8669-050; MK8669-059; ADJ: MK0683-103• Support QC team.



Austarpharma, Shenyang, China

• Chemical Analysis, phase I clinical operation and data analysis

  • Jul 2009 - Oct 2010

  • Phase I clinical research, pre-clinical research and Bioequivalence studies • Research data analysis and writing trial report• Ensuring data quality and accuracy • Tracking ANDA update • Phase I clinical research, pre-clinical research and Bioequivalence studies • Research data analysis and writing trial report• Ensuring data quality and accuracy • Tracking ANDA update



Novartis, Beijing, China

• Reserved GMP Leader

  • Jan 2009 - May 2009

  • Study all sop of every step of production line.• Working as an independent staff in Package workshop. • Learn how to achieve approval of GMP and WHO audit. • Study all sop of every step of production line.• Working as an independent staff in Package workshop. • Learn how to achieve approval of GMP and WHO audit.



Lipu Co.

• sales and Secretary

  • Jul 2004 - Jun 2006

  • Hold product introduction meeting to client.• Prepare meeting slides and design company brochures. • Keep good communication with our clients. • Hold product introduction meeting to client.• Prepare meeting slides and design company brochures. • Keep good communication with our clients.