Member of the Clinical Information Governance
SAS programming:
• Quality control and Consistency checks between CRF Design Guidelines, CDASH guidelines and Sanofi SDTM metadata
• Development Mapping template from CRF to SDTM for data traceability and programming impact analysis
VBA programming:
• Automatize all changes in Tracker SDTM metadata to document release,
• macro SDS compile to generate library of CRF metadata
• Comparison File to highlight changes between versions
Annotated CRF:
• Automatize conversion of file and its import to create library
• Improvement of eMARS process (Automatic CRF SDTM annotation Tool): automatize properties to generate CRF annotations
Support Client in all programming needs: newsletter design, automatize conversion of files …
Data Manager Data base designer (CRF and eCRF)
SAS programmer in Altizem CRO House activity (Nanterre)
janvier 2008 - juillet 2017
• CRF and eCRF designer
• Database creation in Clintrial, SAS, Capture system (EDC) and Excel
• Programming Edit check in Clintrial (Pl/Sql), SAS and EDC
• Data revue report DRR plan and programming listing of DRR in SAS
• Programming deviation plan and validation listing (SAS)
• Programming Patients Profiles
• Import & Exort of Data (Clintrial, SAS and EDC)
• Data quality control (SAS)
• Database pooling & mapping to SDTM (SAS)
Consultant in Data Management
Lundbeck Laboratorie (Paris)
octobre 2007 - janvier 2008
• Data validation of phases IIIb/IV in Psychiatry
Altizem CRO House activity (ClinTrial)
Data Manager
juin 2007 - aujourd'hui
• Data management of phases II and III in oncology and internal medecine
• Data base and Data entry screens design according to case report forms
• Consistency checks programming, management and validation
• Management of Discrepancies
• Quality control
Training of Data Manager (Paris)
CLINACT
avril 2007 - aujourd'hui
• CRF design
• Data validation using SAS v.8
• Consistency checks programming, management and validation
• Data validation with SAS
• Coding of Adverse events, medical history and concomitant treatment (MedDRA, WHO DRUG).
• Data base audit and quality control
• Blind review preparation
• Data base freeze
Clinical Research Assistant (trainee)
Robert Debré Hospital
février 2006 - juin 2006
• Followed inclusions in a clinical study in phase IV of pharmacovigilance
• Presentation of the protocol to the patients included
• To compare the CRF with the medical files
• Monitoring and telephone recall
• To take care of the authenticity and the quality of collection of and management the data
• To make apply the protocol
Analyst-Programmer (Reims)
ICR-champagne
mars 2004 - août 2004
Development of tracking application on web environment
MYSQL, HTML, FLASH, PHOTOSHOP, JAVASCRIPT, VB
trainee in Pharmacology (Nancy)
University of pharmacy
avril 2002 - aujourd'hui
In vivo evaluation of Hexylesther 5-aminolevulinic (hALA) induced protophyrine IX for the
photodynamic treatment of bladder tumors in rats
Researcher in Pharmacology (Nancy)
University of pharmacy
janvier 2002 - mars 2002
Tests in vivo on the rats and in vitro on the healthy and tumoral cells for the treatment of cancer by photodynamic therapy after the instillation of photosensitizing HALA
Études et formations
eCRF training « Capture System » - CLINSIGHT
2010
Qualified diploma in Data Management Clinact (Sèvres)
2007
Training course of investigator for clinical trials University of Paris 7 (Paris)
2006
Professional Master of Computer and scientifics applications (DESS) University of Sciences (Reims)
2004
Master’s degree of science in biomedical technology
2000
Langues
Anglais - C2
Autres compétences
COMPUTER SCIENCES
Data Management: SAS, CLINTRIAL , DataFax, eCRF, Excel
Languages: VBA, SQL, PL/SQL, PHP, Javascript, HTML
Computer tools: Microsoft word, Excel, Access, Powerpoint, Outlook
