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Isabelle LAUGEL

STRASBOURG

En résumé

With a background of mathematician and software developer specialized in security of computer systems and optimization, working in the pharmaceutical industry since 15 years providing training, validation, consulting and support services for Life Sciences applications and business processes to pharmaceutical companies, medical devices companies and CROs of any size worldwide

Founded Life Sciences Expertise in 2011 in order to share experience in Data Management and Drug Safety

Mes compétences :
Essais cliniques
Administration de bases de données
Recherche clinique
Oracle
Pharmacovigilance

Entreprises

  • Life Sciences Expertise - PDG & Consultant

    2011 - maintenant Provide Life Sciences consulting, validation and training
    ->> Data management:
    * Oracle Clinical, RDC and eLoader training
    * Data Management processes training for the Society of Clinical Data Management
    * Oracle Clinical Study Setup
    * Oracle Clinical and RDC support regarding Batch Data Load, programming and Data Extract activities
    - >> Animal health – Drug Safety:
    * Creation of Drug Safety queries and reports on MS Access and MySQL databases
    * Conversion of MS Access Drug Safety system to MySQL database
    * Creation and execution of functional test cases for Drug Safety application
    * Creation of Drug Safety and System Administration training material
    * System Administration and Application support for Drug Safety and Regulatory Database applications
    * Implementation of Signal Detection tool, tool producing PSURs and tool evaluating the number of cases in the future and the corresponding resources for each task
    * Involved in implementation of Datawarehouse
    * Training users in MySQL
    ->> Other:
    * Software testing and Validation
    * Development of Web applications (using javascript, php and MySQL databases)
    * Statistical analyses

  • - - Director of Data Management

    Paris 2010 - 2011 Develop training material and validation package (OHS version 4.6)
    Provide Training classes (OHS versions 4.6 and 4.5.3)
    Provide validation support and application support for Oracle Clinical to customers
    Develop Data Management, Oracle Patch Release and EDC Helpdesk SOPs
    Build SDTM/CDASH Global Library in Oracle Clinical
    Analyze Data Management tools and develop User Requirements (Datalabs, OpenClinica)

  • CSS Informatics - Principal Consultant

    2000 - 2010 Develop training materials and e-learning modules (OHS versions 4.0.x and 4.5.x, Siebel Clinical and PPD Patient Profiles)
    Provide Training classes (Oracle Clinical, RDC, TMS, eLoader and PPD Patient Profiles) to different customers (Pharma Companies and CROs)
    Write, QC and execute functional test modules (OHS versions 4.0.x , 4.5.x, 4.6 – Oracle Clinical, RDC, RDC Onsite and TMS – AERS 4.6.1 – eLoader – PPD Patient Profiles)
    Provide application support for Oracle Clinical, RDC and TMS, including study setup, creation of validation procedures, creation of SQL scripts, OC configuration
    Participate in in-house testing efforts including eLoader loading tool (OC Batch Data Load), OC2SDS (mapping from OC to SDTM standard) and PPD Patient Profiles
    Migration of study data to Oracle Clinical, using eLoader
    Create Patient Profiles Graphical Reports for Client studies
    Development and QC of CDASH/SDTM Oracle Clinical Global Library
    Process review and creation of SOPs/WI for customers

  • Quintiles - Oracle Clinical DBA

    Durham 1999 - 2000 Setup and maintain studies in Oracle Clinical
    Create and test Validation and Derivation procedures
    PL/SQL programming
    Report programming using Brio Query
    Conduct Oracle Clinical training
    OC upgrade activities for Freiburg and Edinburgh to allow smooth transition to year 2000
    Develop Page Tracking Tool using Oracle Forms

  • ISV - Responsable Informatique

    1994 - 1998 Develop and maintain Dataflex databases to manage the production, inventory, sales, billing and information transfer to all representatives of the company.
    Provide application development for marketing applications using Access.
    Provide Help desk support

  • European Science Foundation - Analyste programmeur

    1994 - 1994 Develop applications in Pascal and Visual Basic
    Provide Help desk support

  • Tokos - Analyste Programmeur

    1993 - 1993 Design financial applications in Microbol
    Perform customized evaluations to allow customers to monitor their investments over time

Formations

Annuaire des membres :