- Solid background in medicine with many years of clinical work experiences as a medical doctor speciafied in gynecology and obstetrician (home country).
- Pharmaceutical work experiences with phase I - III clinical trials in oncology area with a role of clinical research physician / clinical development manager (Belgium).
- 3 years of epidemiology research experience as a researcher, also responsible of project management and coordination.
- Master in public health methhodology with emphasis on epidemiology and statistics in medicine.
- Master of science in molecular biology and biotechnology with lab work experience in Gene Therapy.
- Bachelor in Meicine
- Statistical package: descriptive analysis, GLMs, with SPSS, STATA, training on SAS & R
- Strong computer skills: Windows / Mac system, MS Word, Excel, Powerpoint, Outlook
- Data analysis skills: Excel, Access, SQL2012, PivotTable, Macro, VBA.
- Training in evidence base medicine methodology (systametic review, meta-analysis)
- Training on statistical methods and SAS. R
- training on research design
Researcher, Project Management & Coordination Belgium
Since August 2012
Working with an European Commission FP7 collaborative research project in public health field:
- Independent work on project day-to-day management of a large scale project with 300 study sites, scientific liaisonand project coordination within the consortium in international settings.
- Study sites section, feasibility assessment, randomization, RCT monitoring, budget management and reallocation, project ethical application.
- Scientific writing on the development of study protocols, project deliverables, guidelines and project reports to the European Commission, conference abstracts /posters and scientific articles. Review and comments on all project documents that developed by other partners.
- Data collection questionnaire design, data quality controland analysis with SPSS, STAT and SAS.
- Effective and efficient communication with consortium partners (EU & China), project administrative activities (incl. conduct TCs and face-to-face meetings, development ofmeetingagenda/minutes, project newsletter and leaflets, maintain project website).
- Feasibility assessment of new proposals, conducted literature reviews, contributed to research translation (documents development and activities).
Database Design and Analysis / Reporting with Access and SQL, Data Visualization Belgium, WI, United States
September 2011 --- July 2012
- Database design with MS Access and SQL
- Store Excel data in a structured, relational database
- Easily move data between Excel and Access using VBA, and SQL
- Use Excel pivot tables with Access data
- Linking Excel worksheets to Access
- Table join
- Analyzing Excel data with Access queries
- Reporting Access data using Excel presentation layer
- Find duplicate data with Access and SQL queries
- ETL skills: extraction, Transfer, Loading data using Access, SQL.
- Data visualization tools: Tableau
Clinical Development Manager Belgium
May 2011 --- August 2011
Working with phase II – III oncology trials with main contributions to:
- Medical review on patient profileswith EDC system
- Evaluation of eligibility, safety, efficacy and protocol compliance
- Answering of medical related questions to data management / data coordination departments in different disease settings
- Development of medical monitoring listings with SQL/Oracle databases
- AE/SAE reviewand assessment, ensuring AE/SAE coding accuracy and consistency with MedDRA13.1
Clinical Research Physician Belgium
November 2010 --- February 2011
Workingwith5 phase II - III trials in cancer treatment,mainly contributed to:
- Answering of medical related questions to CDM depart. and pharmacovigilance unit.
- Oversee feasibility assessment and site identification,CRF review and approval,budget negotiations with study sites.
- Medical Review Plan development and implementation.
- Performing medical review with patient profiles on the eligibility, safety, efficacy and protocol compliance, ensuringquality of the data.
- Involved in catalyzing new proposals and ethical review of the projects.
Clinical Data Manager (DM) Belgium
March 2010 --- June 2010
Working with phase I trials in anticancer drug development (Neuro-Oncology area)
- Clinical data cleansing with EDC system (PDS)
- Generate queries, create data reports with Excel
- Data reporting with iReview and received CDTM training
Lab volunteer in Gene therapy Belgium
May 2007 --- August 2007
- Lab work in the area of Gene Therapy with a project of AAV Vectors and Control of Their Tropism to Target Organs (KUL).
Laboratory work skills:
- Cell culture and monocyte isolation
- Protein study techniques: ELISA, Western blot, histology (sectioning & immunofluorescence staining)
- DNA and mRNA study techniques: DNA extraction, PCR and agarose gel electrophoresis
- In vitro cytotoxicity phenotype assays: Comet assay, MN assay
- DNA alignment
- Animal work: eye bleeding, tail vein / peritoneum injection, organ dissection
Medical Doctor China
July 1990 --- September 2000
Responsibilities and achievements including:
- Routine clinical work (medical consultation, diagnosis and medicament/operational treatment, patients’ management) in academic hospitals (China).
- Improved workflow for clinical consulting, diagnosis and treatment in routine clinical work, which contributed to more efficiency workflow from out-patient section to inpatient section (China).
- Research assistant in the area of Reproductive Immunology and Birth Asphyxia.
TrustOrientationProblem solvingKindnessIndependenceDependabilityAnalytical thinkingFlexibilityAdaptabilityInterest in knowledgeService orientedCreative thinkingEfficiencyCollaborationOrganization
Protocol Phase IoncologyMicrosoft OfficeMicrosoft Excelmolecular biologyImmunologyICH-GCPGynecologic oncologyGynecologyPhase IIPhase IIIProject ManagementInformed Consent DocumentsVaccinesSearch literature on clinical trialsWomens HealthUnderstand how results translate to practiceStatisticsPowerPointPhase IVGood Clinical Practice (GCP) Medical devicesClinical trial managementClinical DevelopmentClinical Data Management (CDM) BiostatisticsScientific methodologyScientific WritingMedical writingMedical oncology Clinical researchClinical Study DesignEthics submission and approval processEnglishEDCData ManagementData AnalysisCancerClinical trialsClinical monitoringClinical study reportsMedical consulting
Skills and Expertise
Analyze data Build and manage the Trial Master File (TMF) Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Write papersAdverse event reportingApprove monitoring reportsAssess adverse reactionsAssess site feasibilityCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCoordinate with the ethics commiteecoordinating research projectsData codingApprove patient informationDevelop study timelinesManage clinical trial files/documentsManuscript preparation and reviewReview study protocolsReport dataRead medical literatureSchedule trial visitswrite and maintain clinical evaluation reportsWrite combined statistical and medical reportsWrite protocolsWritten presentation
Master in Public health methodology from UniversitéLibre de Bruxelles (ULB), Belgium in 2010
Master in Molecular Biology from Vrije Universiteit Brussel (VUB), Belgium in 2001
Bachelor in Medicine from Henan Medical University, China in 1989
Training and Certification
Evidence Based Medicine, systametic review and meta-analysis in 2014 Training
Statistics (GLMs: Linear/Logistic/Cox regression, Parametric / Non-parametric tests, Multilevel Analysis) in 2014 Training
training on SAS and R in 2012 Training