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
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
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
infopro (www.infopro.com.my) is an ISO 9001:2000 certified total banking system provider. established in 1987, infopro is now a global banking solution provider which embraces the most advanced technologies and the best global banking practices in the development of its flagship banking solution - eicba system. icba system is a fully integrated banking solution, designed to meet the needs of global financial institutions. icba system offers one of the most comprehensive integrated banking system which provides the full spectrum of the conventional banking and islamic banking Operations at both front office and back office functions covering Retail, wholesale, general ledger and electronic banking modules.icba system is implemented in different countries at different banks such as • bsn(bank simpanan nasional ) • sme bank • ghavamin (iranian bank) • toyota malaysia
Oracle developerOctober 2006 --- August 2007
tarroo incorporated is a us based Software house which has a branch in malaysia. at tarroo i have had great opportunities to uplift my technical knowledge as well as my Communication Skills. i have been working with different clients using the latest oracle technology which is both scalable and flexible in design. the main projects i was involved with were bizwire and flitwiz where enhancing the Software packages was required with adding new forms and reports, modifying exciting procedures , triggers and packages, being on site for implementing new changes. implementation of these erps covered production Planning, production, Purchasing, inventory, plan&machinery, safety, r&d,technical, Industrial engineering, and Accounting.
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