Freelancer profile translated to English.

Description

With over twenty years of experience, we offer our services to pharmaceutical, biotech, and CRO companies, in human or animal health, providing consulting, training, validation, application development, in data management or pharmacovigilance.

- Selection of the most suitable application for your specific needs

- Validation

* Creation, testing, or evaluation of IT applications

* Creation of software validation documents

- Training

* Creation of training material and e-learning modules for data management or pharmacovigilance applications

* Facilitation of training sessions (on-site or online)

* Provision of our e-learning tool

- Optimization of your activities

* Creation of SOPs and Working Instructions

* Application development

- When you are in production

* Support and consulting for data management or pharmacovigilance applications (including, for example, Oracle Clinical, eLoader, Argus)

* Definition of studies in Oracle Clinical, Inform, Medrio, or Medidata Rave, including validation procedures (edit checks), SQL scripts, and listings

* Implementation of new working environments (CDISC Standards, Risk Based Monitoring, ...)

* Statistical analyses or data summaries for use in pharmacovigilance or signal detection

* Data migration

Languages

German
Fluent
English
Fluent
French
Native or bilingual

Workplace preferences

Can work on-site

Strasbourg (up to 50km)

Life Sciences Expertise
CEO & 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

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DEA in Cryptography, Formal Computation and Optimization
Faculty of Sciences of the University of Limoges
1992
Master's Degree in Discrete Mathematics
University Louis Pasteur, Strasbourg
1991

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Isabelle Laugel

Clinical Data Management Consultant

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