Senior Clinical Data Manager
Since September 2016
Data Management for GSK Vaccines:
• Designing of CRF (Central Designer)
• Development of SAS programmes
• Performances of tests, writing of UATs, validation of user tests
• Respect of quality commitments
• Participating in the continual improvement of the Quality System
• Control of SAS (SAS BASE, SAS STAT, SAS GRAPH, SAS MACRO)
• Creation of the database
• Tracking of CRFs, Data entry (single and double),Importing external data
• Writing of Data Validation Plan, Programming validation tests
• Management of queries, Quality control of data
• Database lock, Data transfer
clinical data programmerMechelen, Belgium
Since November 2011
SGS Life Science Services (a division of SGS Belgium) is active in all aspects of clinical research for pharmaceutical and biotechnology companies (coordination and clinical trials via data processing and statistical analysis to compile the reports).
Working as a Sr Clinical data programmer:
- Set up the whole data conversion from A-Z from eClinicalOS to SDTM format
- Solving conversion issues within different EDC platforms such as InForm, Rave, eClinicalOS
- Solving Quality Control problems issued by our sponsors or CDMs
- Review, create & file documents (annotated eCRF, tsDTAs and so on).
- Maintaining contacts with suppliers of external data; Programming activities such as Upload external data and perform the quality checks.
- Programming electronic checks/listings and conversion scripts in PL/SQL
- Provide support towards lead CDM in technical issues
- Performing Database Freeze and Lock in collaboration with other colleagues in the team.
- In collaboration with another CDP, creating the latest version and tuning existing version of define.xml
- Creating progress reports using PL/SQL packages according to the sponsors’ requirements
SQL Developer/ApexOctober 2010 --- May 2011
Working as an Apex developer: Try to discover the technology and find the best practices out of it. Designing small data models and writing packages in order to avoid direct access of an apex user to database.
software engineer (oracle developer)September 2007 --- November 2008
Oracle developerOctober 2006 --- August 2007
Trainee (Jsp developer)July 2006 --- October 2006
Attention to detailCommunicativeCritical thinkingFlexibilityInterest in knowledgeResult OrientedResponsibilitySociabilityProblem solvingKindnessAdaptability
CDISCClinical study reportsCommunication SkillsCRFCRODatabase design and maintenanceDatabaseseCRFICH guidelinesLife SciencesOracle ClinicalPhase IIIPhase IIProblem SolvingProgrammingSQLStability tests
Bachelor in Information Technology - Information System Engineering from in 0000