Implemented knowledge of ICH GCP and CDISC Standards. Proven organizational skills with the ability to learn quickly; excellent time management, meet tight deadlines; manage multiple tasks and changing priorities while working in a high-pressured environment. Reputable for my attention to detail skills and strong ability to respond and solve problems in real time to fulfill customer expectations. Ability to work effectively in both an independent and team environment.

COMPANY	POSITION HELD	DATES WORKED
(Confidential)	Clinical Data Manager	3/2009 - Present
Averion International Corp.	Data Specialist	9/2007 - 2/2009
IMS Health	Data Manager	8/2001 - 6/2005

SCHOOL	MAJOR	YEAR	DEGREE
Kriger Research Center Inc	Clinical Data Management Professional Development Program	2009	Certification Degree
Beijing Medical University (Peking University Health Science Center)	Medicine	1996	Bachelor Degree

Highlights:

P&L responsibilities
Presentation
Technology Solutions
Sales Support
SQL language
MS Office Applications, Lotus Notes
FoxPro, SPSS, SourceSafe
ClinAccess, Clintrial

• organized
• data
• bilingual
• pharmaceutical
• SQL Language
• SAS
• ClinTrial
• ClinAccess
• detail oriented

Responsible for data management plan development (includes database specifications, edit checks, data review guidelines, annotated CRF, critical variables list, etc.), CRF tracking and inventory, CRF data verification, CRF data validation. Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards. Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data.