Pascale Youinou

Data Management from phases I to IV clinical trials in various therapeutic domains (anti-infectious, neurosciences, cardiovascular, oncology):
•Data validation and cleaning, eCRFs and paper CRFs, discrepancy management, data listings
•Quality control
Preparing and Review of CRFs, Data Review and Analysis Plans for local trials outsourced to CROs
Delivering training for Data Management topics ensuring the quality, consistency, and integration of study data through coordination and leading activities to Site Monitors or Site personnel (queries, EDC, CRF completion).
Excellent user knowledge of:
•Oracle Clinical Remote Data Capture (Electronic Data Capture)
•Oracle Clinical (version 4.5.1)

Sector: Health and pharmaceutical

Data Management in phases II, III and IV studies in various therapeutic domains (gynecology, hematology, soft traumatology, diabetes...) for pharmaceutical firms (Servier, Bayer, Applied Pharma Research, Zambon...)
•Design of Clintrial® 4.1 and 4.3 databases,
•Programming and quality control (PL/SQL, Clintrial, SAS…),
•Data validation, data cleaning, queries management, data listings using SAS (version 8) and SQL (Oracle 8) requests
•Writing and Review of Data Review Plans and Trial documentation
•Writing and Review of SOP

Sector: Health and pharmaceutical

Involved in “Iberia Plus” project for Iberia.
Development and adjustment of Oracle tools in order to perform database and Web applications.
Final tests with client database. Maintenance of product.
Writing of technical papers and help manuals.
Excellent knowledge of Oracle tools Designer and Developper/2000 (Oracle version 7), SQL Navigator, SQL and PL/SQL programming.

Sector: Computer services