You're seeing this page as if you were . The main menu is still yours, though. Exit from immersion
Malt Strategy
Isabelle LaugelIL

Isabelle Laugel

Consultant en Gestion de Données Cliniques

€800/day
Strasbourg, FR
8-15 years

Average response time: 1 hour

About Isabelle

Avec plus de vingt ans d'expérience nous proposons nos services aux sociétés pharmaceutiques, biotech et CRO, santé humaine ou santé animale, proposant conseil, formation, validation, développement d'applications, en data management ou pharmacovigilance

- Sélection de l'application la plus adaptée à vos besoins spécifiques

- Validation
* Création, test ou évaluation d'applications informatiques
* Création de documents de validation de logiciels

- Formation
* Création de matériel de formation et modules e-learning pour des applications de data management ou pharmacovigilance
* Animation de sessions de formation (sur site ou par internet)
* Mise à disposition de notre outil de e-learning

- Optimisation de vos activités
* Création de SOPs et Working Instructions
* Développement d’applications

- Lorsque vous êtes en production
* Support et conseil pour les applications de data management ou pharmacovigilance (incluant par exemple Oracle Clinical, eLoader, Argus)
* Définition d'études Oracle Clinical, Inform, Medrio ou Medidata Rave, incluant les procédures de validation (edit checks), scripts SQL et listings
* Implémentation de nouveaux environnements de travail (Standards CDISC, Risk Based Monitoring, ...)
* Analyses statistiques ou états de données pour utilisation en pharmacovigilance ou détection de signal
* Migration de données

  • German

    Fluent

  • English

    Fluent

  • French

    Native or bilingual

Can work on-site
Strasbourg (up to 50km)

Experience

  • Life Sciences Expertise
    PDG & Consultant
    CONSULTING AND AUDITS
    Strasbourg, France
    Provide Life Sciences consulting, validation and training
    • Data Management:
    o Oracle Clinical, RDC and eLoader training (versions 4.6 and 5.0.1)
    o Data Management processes training for the Society of Clinical Data Management
    o Oracle Clinical Study Setup (Database build, edit checks and custom views)
    o Oracle Clinical and RDC support regarding Batch Data Load, programming and Data Extract activities
    • Animal Health – Drug Safety:
    o Creation of Drug Safety queries and reports on MS Access and MySQL databases
    o Conversion of MS Access Drug Safety system to MySQL database
    o Creation and execution of functional test cases for Drug Safety application
    o Creation of Drug Safety and System Administration training material
    o System Administration and Application support for Drug Safety and Regulatory Database applications
    o 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
    o Training users in MySQL
    o Involved in implementation of Datawarehouse
    o Development of Data Analyze application allowing building SQL queries and showing the result using various display types (HTML, Excel, RTF, FDF, graphs)
    • Other:
    o Software testing and Validation
    o Development of Web applications (using JavaScript, php and MySQL databases)
    o Statistical analyses
    o Development of Training material (standard Powerpoint presentations and development of an eLearning Web application)
  • Pharmasol
    Director of Data Management
    CONSULTING AND AUDITS
    Strasbourg, France
    • 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)
  • Quintiles
    Oracle Clinical DBA
    PHARMACEUTICALS INDUSTRY
    Strasbourg, France
    • 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
Check out Isabelle's experience

Recommendations

Be the first to recommend Isabelle

Help this freelancer shine by sharing your experience working together.

These freelancer profiles also match your criteria

AgathaA

Agatha Frydrych

Backend Java Software Engineer

4.7

(3)

2

BaptisteB

Baptiste Duhen

Fullstack developer

4.6

(4)

5

AmedA

Amed Hamou

Senior Lead Developer

4

(2)

7

AudreyA

Audrey Champion

Web developer

4.3

(3)

4

Signup to reveal

Education

  • DEA de Cryptographie, Calcul Formel et Optimisation
    Faculté des Sciences de l’Université de Limoges
    1992
  • Maîtrise de Mathématiques Discrètes
    Université Louis Pasteur, Strasbourg
    1991
Check out Isabelle's education

Skill set (28)

Gestion de données cliniques
Pharmacovigilance
Industrie Pharmaceutique
EDC
Validation
Formation
CDISC
GCP
21 CFR Part 11
SOP
Risk Based Monitoring
Clinical Data Management
Analyses Statistiques
Santé Animale
Oracle Clinical
RDC
TMS
Eloader
Medrio
Inform
Medidata Rave
Argus
ArisG
Programmation
PL/SQL
MySQL
PHP
JavaScript

Categories

  • Other