Souad - Data Scientist DATA

EXPERIENCES

Process Referent
*Since
08/2017
Clinical Operation Department, Servier - International Research Institute, Suresnes, France
Set up and continuous improvement of data management processes
Problem resolution, support and training
Data Capture standardization
Process improvement
Support and problem resolving
Risk Based Management and central monitoring:
Participation to the tools set up for risk based management
Central monitoring process follow up : data surveillance meetings, Key performance indicator
definition, communication tool set up with the centers
Set up and continuous oversight of CROs :
Vendors selection, key performance indicators definition and follow up , forecast and billing
Speaker at Outsourcing in Clinical Trials Europe (May2019): “How to maximize Vendors
Engagement in a study”
Involvement in the IMI project, C4C (care for children), as data manager expert
Trainees supervision

Data manager coordinator
*2015/2017 KBP, Keyrus Biopharma, Levallois Perret, France
Study set up :
Protocol review
Redaction of data management plan, data validation plan and deviation detection plan
Implementation of EDC and User acceptance test organization
Participation to the set-up of the monitoring strategy
Monitoring meeting participation
Study Conduct :
Ensure ongoing and timely data capture and data cleaning, including external data sources
CRO’s training and follow up
Central monitoring
Preparatory review and data surveillance meeting organization
Study end management
Coordination of study end activities
Blind Review organization
Data base lock
Individual data specification
Therapeutic Area: oncology

Data Manager
*2013/2014 RPS, Research Pharmaceutical Services, Caen, France
Review clinical data as per SOP, protocol, and study specific guidelines
Assist with clinical database closeout activities, including listing review and audit activities
Therapeutics Area: phlebology, cardiology and oncology.

Quality and project manager
*2011/2012 Proval Bionat, Cosmetics and Dermatologic products company - Valence, France.
Project management
Customers and Suppliers contact.
New product formulation development.
Quality system set up.
Continuous improvement

Internships
*2011
*2010
Debiopharm, Biopharmaceutical company – Gland, Switzerland.
Protein formulation and development of a method to characterize protein aggregation
Protein pre-formulation development in order to solve aggregation problems.
Protocols establishing for wet mill use and nano-formulation of nano-suspensions.
*2009 Fundamental and applied bioenergetics, INSERM laboratory, Grenoble, France
Study of the relationship between the permeability trasition pore (PTP) and complex I of the
mitochondrial respiratory chain.
Cell Culture, HeLa Cell transfection with ARNi.