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Xavier CORNEN

Paris

Electionseuropéennes 2024

RETROUVEZ GRATUITEMENTLe résultat des européennes à Charly ainsi que le résultat des européennes dans le Cher.

En résumé

J'ai mis en place deux services de data management : définition des process et des interractions avec les différents acteurs d'une étude clinique, écriture des procédures relatives aux data management, mise en place des standards

Mon travail quotidien consiste à manager des projets de data management confiés à des CROs, de l'écriture de l'appel d'offre à la relecture du rapport d'étude clinique tant au niveau des délais, de la qualité que du budget.

J'ai mis en place de nombreuses études utilisant différents CRFs électroniques (medidata, inform, quadratek, l'e-CRF de lincoln).

Je maitrise SAS et j'ai une Solides connaissance des BPCs et du SDTM du CDISC

Mes compétences :
data management
Oncology
sas programming
Reconciliations
MedDRA
HTML
CDISC
Visual Basic
Transplant
21 CFR Part 11
Standard Operating Procedure
Serology
SQL
Request for Proposal
Quality Assurance
Management of CRO
JavaScript
Internal Medicine
Infectious Diseases
ICH/ BPC
Gastroenterology
GAMP
Electronic Data Capture
Database Design
Cardiology
CRO supervision KPI
CRF design
Audit
Assurance Quality Data Management

Entreprises

  • Sanofi Pasteur MSD - Senior Clinical Data manager Europe

    Paris 2005 - maintenant Responsible of corporate data management activities

    * Data management service set up ;
    * Implementation of data management standard processes for all Sanofi Pasteur MSD studies (Corporate and Europeans affiliates) in accordance with GCP ;
    * Responsible for the development & maintenance of Assurance Quality Data Management documents ;
    * Standardisation of tasks (templates, quality controls,...) and tools (Standard database library,CDISC- SDTM ...). ;
    * Implementation of EDC activity ;
    * Participation to EDC provider qualification with auditor using GAMP methodology, CFR 21 Part 11
    Inform (Phase forward), lincoln system tool, clincase (quadratek)
    * Set up innovative solutions to help other departments (safety follow up for pharmacovigilance department, blood sample and IMP follow up, protocol deviations identification...) ;
    * Management of CRO and communication with others department ;
    * Technical Organisation and projects follow-up: cleaning, coding (WHO Drug, MedDRA), SAE reconciliation, quality control using SAS, blind review, Data Management Report, mapping
    * Timelines follow-up ;
    * Main contact for data management activities with others departments :
    * Monitoring (collaborative organisation)
    * Statistics (SDTM, Adam) ;
    * Medical writer (Protocol and Clinical Study Report contributor and reviewer)
    * Pharmacovigilance department (participation to ASR , PSUR, DSUR, SAE reconciliation),
    * Quality Assurance (Audit, SOP)
    * Share holders : Merck US and Sanofi Pasteur. ;
    * Central labs (import of serology results (PPD, and Sanofi Pasteur lab) ;
    * Budget follow up ;
    * Choice of the CROs : Request For Proposal writing, negotiation, contracts, invoices follow up ;
    * Budget estimate

    * Management of data manager ;
    * Recruitment and management ;

  • ROCHE - Clinical Data manager

    Boulogne-Billancourt 1999 - 2005 Responsible of clinical and epidemiologic data management activities for Roche french affiliate

    (Therapeutic areas : transplantation, oncology, infectious diseases, internal medicine, cardiology.)
    average 15 studies/year

    * Setting up of standards and SOPs for data management activities
    * Definition of standard CRF libraries, Request for proposal, Data Handling Manual templates
    * Set up of standard data bases using CDISC (SDTM) ;
    * SOP writing
    * CRO supervision ;
    * Organisation of tasks (cleaning steps, coding with MedDRA, Who drug, SAE reconciliation, Quality control, Blind review ) planning and deliverables
    * Budget follow up ;
    * Creation of reporting tool for biometric activities ;
    * Implementation of Electronic Data Capture :
    * With several providers: Lincoln, Macro (Infermed), home made EDC (Unilog) ;
    * Design, planning and validation following the CRF part 11 regulation. ;
    * Training of physicians and ROCHE users.
    * SAS Technical leader for biometric unit ;

  • Lincoln system - Statistician & Datamanager

    1997 - 1999 Studies follow-up of biometric activities from CRF design to final statistical report

    * Data management ;
    * Database design : SAS data base creation and definition ;
    * Databases mapping/import for statistical analyses (ie: ASCII file to SAS,...) ;
    * Data handling manual Writing ;
    * Queries generation, coding and databases lock

    * Statistic analyses
    * Tables, listings and figures programming
    * ICH report writing.

    * Other projects ;
    * Patient profile design and programming with EXCEL and VISUAL BASIC .
    First Web EDC french study :
    - laptop set up, and users training.
    - Data management ;
    - Programming of Patient profile in HTML format by using SAS data base.

  • CHUGAI RHONE POULENC - Statistician trainee

    1996 - 1996 * Definition and programming of patient data listings. ;
    * Statistical table and figures programming using SAS for phase II and III in oncology ;

Formations

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