Meet The Team

Yun Lu, PhD

Director, Data Management and Standards

Yun Lu portraitYun Lu is responsible for the overall development efforts of the Clinical Data Management Systems Team at KAI. Dr. Lu has over 15 years’ experience leading clinical data management, clinical data standard development and implementation, information technology integration, eSolution development and life cycle validation, and staff training. She supervises a group of clinical data managers, data analysts, and database programmers and interacts with clients to ensure KAI’s clinical and health care data management approach, systems, and documentation meet their needs.

As a senior clinical data manager, Dr. Lu provides hands-on expertise in all data management activities related to the preparation and implementation of clinical trials and contributes to the technical infrastructure of data management and process improvement. She is responsible for each study’s data management plan (DMP), Case Report Form (CRF) design, quality control, database validation, and ongoing data management progress.

Dr. Lu leads the KAI data standards team supporting the National Cancer Institute (NCI) Cancer Data Standards Registry and Repository (caDSR) Common Data Element (CDE) and metadata curation service. The focus includes ISO/IEC 11179, vocabularies and metadata, the caDSR curation tool, the CDE Browser, and the Form Builder tool. As an electronic data capture (EDC) and data management subject matter expert, Dr. Lu works with content and software teams to improve data collection and data management quality and efficiency, supports the development and use of the NCI Standard eCRF Modules, and provides NCI standards consultation as well as caDSR curation and form building instruction. She works closely with the staffs of the Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Informatics Program and is an acting member of the CDISC CDASH Substream, the CDISC Therapeutic Data Standards Working Group, and the CDISC QS/FT (Questionnaire and Functional Test) Workgroup.

Dr. Lu works with the KAI CDE team to convert legacy clinical trial data into the CDISC format for data repositories and is experienced in the Extract-Transform-Load (ETL) process of CDEs. Her expertise also includes data architecture analysis and design, data governance, data mapping across clinical systems, Military Health System Data Repositories (MDRs), and data warehouses.

As the principal developer of KAI’s Internet-accessible EDC system, the OpenClinica Enterprise application, she leads study setup, performs eCRF development, edits and checks programming, develops reports to support data management and analysis, and incorporates CDISC SDTM and CDASH standards into the EDC system.

Dr. Lu holds a doctorate of philosophy in biophysics/biochemistry from the Medical College of Ohio in Toledo, Ohio. Dr. Lu was a postdoctoral researcher at the University of Pennsylvania School of Medicine and a postdoctoral fellow for the National Institute of Diabetes and Digestive and Kidney Diseases(NIDDK). She holds a bachelor of science degree in environmental chemistry from NanKai University in Tianjin, People’s Republic of China.

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