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Axessio
- Consultant Senior
PARIS
2018 - maintenant
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Didaxis
- Coordinateur projet
Paris
2014 - 2016
Amélioration de modèles pharmacologiques vivo :
- Business Process mapping,
- Sélection de solution,
- Gestion d'une équipe multidisciplinaire d'experts internes et externes
- Analyse de signaux (video, accelerometrie, EEG,...) and application de modèles bayesiens
Vainqueur du Bio IT world Best Practices Awards 2015 : Research & Drug Discovery: UCB BioPharma - Automated Accelerometric Detection of Epileptic Seizures in Rodents
Utilisation de Device dans le cadre d'une étude clinique:
-Intégration réglementaire
-Dataflow
-Préparation à l'analyse exploratoire de données
-Gestion de projet
Projet additionnel pour for IT : Remote Control & Monitoring for High Pressure Lab - Gestion de projet
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New Medicines - UCB
- CNS Technology Project manager & Ethologist
2014 - maintenant
CNS Technology Project manager & Ethologist, New Medicines - UCB - Braine l'Alleud (Belgium)
Harvey Nash / Didaxis - Paris
Project manager for in-vivo pharmacology model improvement (Parkinson & Epilepsy)
- Selection & implementation of the technology solution
- Lead of multi-disciplinary team composed of internal and external experts
- Signal analysis (video, accelerometry, pressure, EEG,...) and application of Bayesian statistics
Project manager for Global Exploratory Development : Exploratory use of Mobile Device during Clinical Trial (Phase 2a).
- Management of regulatory, technologic and legal aspects
- Lead of data analytics activities related to the project
Additional project for IT department : Remote Control & Monitoring for High Pressure Lab - Project manager (6 months)
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Didaxis
- IT Project leader / Team leader
Paris
2010 - 2014
Pour le compte d'un laboratoire pharmaceutique belge:
- mai-decembre 2013 : Team leader ad interim : IT Data Capture & visualization - 6personnes
- Group leader du projet System landscape / ITSM / CMDB (inventaire/maintenance des applications New Medicines) et participation aux initiatives Translational Medicines
-Mise en place du système de gestion de bioéchantillons cliniques utilisés dans la recherche de biomarqueurs: audit fournisseurs, définition des besoins et de process, validation.
-Implementation d'un système d'acquisition de comportement par analyse d'image : formation, automatisation, configuration et optimisation de process, support brevet.
-Implémentation d’une plate forme intégrée de modélisation PK/PD Phoenix (WinNonLin, PKS, NLME)
-Implémentation d’un système de gestion de code source (Subversion/Eclipse) pour les biostatisticiens.
-Support aux utilisateurs (niveau 2 & 3) d’outils de modélisation (développement clinique et préclinique, recherche)
-Gestion des changements : CAPA, documentation.
-Support SharePoint
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IT New Medicines - UCB
- Senior Project Leader
2010 - 2014
IT New Medicines - UCB - Braine l'Alleud (Belgium)
Harvey Nash / Didaxis - Paris
- Project manager and data scientist for the implementation of behavior acquisition system (Ethovision) for the in vivo Pharmacology department. Additional development has led to the automated measurement of the quality of movement in a
Parkinson model. The use of this system and additional raw data analysis has allowed UCB scientists to step forward in the discrimination of treatment effects and has led to the submission of a patent for a potential treatment for Parkinson disease.
System installation and optimisation and data analysis automation for various other models (Y Maze, Water Maze, Plus Maze...). Integration of automated and manual behavior acquisition systems (Ethovision & Observer)
- Project manager for the extension of seizure detection system (Accelerometry & video) for the Epilepsy group. Coordination with the external providers (algorithm & software development) and internal IT department (2015 Bio-IT World Best Practices Awards Winner)
- Implementation (IT & data Compliance) of a biobanking management process for sample coming clinical trials used for Omics purpose. Biobank selection & negotiation with the CRO, data and logistic process definition, coordination with Digital & Clinical
QA.
- Animal Care system, vendor selection and budget definition
- Activity Base upgrade on both Research sites (UK, Belgium)- Project Manager
- Project manager for the implementation and validation of Subversion version control system to support the statisticians in Global Exploratory Development as well as Sharepoint developpers. Integration with R statistics programming software.
- Ad interim IT Data Capture team leader (8 months) : Budget preparation (CAPEX / OPEX) and business cases definition (ROI), team management (5 people on UK and Belgium sites), audit and inspection preparation.
- System landscape initiative (Group leader) consolidation of information about all computerized systems used in the New Medicines department, identification of
critical data sources and definition of business services to support the translational medicines initiatives
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IT New Medicines Braine l'Alleud
- Validation Engineer
2007 - 2010
Validation Engineer, New Medicines IT - UCB - Braine l'Alleud (Belgium)
Tescom Intl - Paris
- Implementation and validation of a clinical data warehouse dedicated to pharmacokinetics data and modeling results (PKS). Interface with the WATSON LIMS and clinical datasets (CDISC, SDTM format).
- Definition of the validation strategy and Global Validation Plan for Modeling & Simulation and Statistical Analysis systems (NONMEM, Phoenix/WinNonLin, R/OpenBUGS, PK SIM, JMP for SAS,...)
- Operational management: definition of the incident management process for the IT Modeling and Simulation team, user support for modeling and simulation applications, systems administration.
- Mission for the SAP IT team: Definition of the ERP upgrade to SAPECC and validation strategy (6 months contract) ;
- For a specialty orthopaedic company : CE marking and ISO 13485:2003 certification strategy of a software used as a Class I Medical Device (3 month contract)
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Tescom
- Coordinateur / Chef de projet IT
Puteaux
2007 - 2010
Mission de définition de la stratégie de validation (Plan Maitre de Validation)dans le cadre de la migration SAPECC (6 mois)
j'ai ensuite mené depuis différentes missions en support IT au groupe de développement exploratoire :
- définition de la stratégie de validation des systèmes de modélisation et analyse statistiques : open source, systèmes configurés, outils utilisés en recherche exploratorie et dans un cadre réglementé, etc
- coordination projet
- support niveau 3
- change & Access management
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ASSYSTEM
- Consultant validation SI
Courbevoie
2003 - 2007
Validation de divers systèmes de supervision, de suivi environnemental et de production (SNCC) pour le compte d'industries pharmaceutiques, principalement SANOFI PASTEUR. Principales missions :
Coordonner les qualifications opérationnelle et de performance du Système de Contrôle Commande (fonctions transverses) d'un bâtiment neuf.
Validation des dossiers de lots (> 100 recettes)
Validation de systèmes de suivi environnementaux des principaux bâtiments de production/ conditionnement/ stockage/ animalerie
Qualifier un système de Transitique et interfaces avec SAP.
Qualifier un système de supervision de fermenteurs.
Qualifier deux cytogénérateurs (SCC) utilisés dans le cadre de projets cliniques phase II.
En parallèle, rôle de responsable SI pour l'agence de Lyon.
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SANOFI
- Senior Validation engineer
Paris
2003 - 2007
Senior Validation engineer / SANOFI PASTEUR Marcy l'Etoile (France)
ASSYSTEM France - Life sciences dept- Vénissieux
- For a process control system for a new vaccine production line (P3 containment): definition of the OQ and PQ strategy, coordination of the execution with external contractors and key users. Manage the planning and priorities with the end users:
validation had to be done at the same time as the production line process testing and equipment cleaning.
- Coordination and execution of the validation of more than 100 recipe batch reports (production, sterilization, monitoring)
- For the systems of building environment monitoring (15 independent systems): analysis and remediation of the existing system design and validation plans, customization for each building specificities. Upgrade to ensure the compliance with 21 CFR part 11 regulation.
- Validation coordination and execution for various equipments and computerized systems:
- Transitic system and its interface with the ERP (SAP WM).
- Fermentor process control system and two cytogenerators used in R&D (Phase II projects).
- For other clients (Ipsen, Solvay, Aventis Pharma, Cermex,...) : Qualification (IQ / OQ) and audit of manufacturing systems (
tablet press, coater, docking systems, monitoring systems).
- For ASSYSTEM as IT referent for Lyon agency : Ensure coordination with other engineering groups, training coordination and
workgroups animation, definition of service contracts and requests for proposal.
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AVENTIS PHARMA
- Project Manager
Antony
2001 - 2003
In Vitro R&D Department - AVENTIS PHARMA - Vitry / Alfortville (France)
ADESIUM - Saint Quentin En Yvelines
Automation project aiming at replacing the R&D experiment paper notebook by an electronic devices (PDA) to be able to
quickly extract reports and increase data quality.
The system allowed user friendly data acquisition and analysis for common memory tests (Y Maze, Plus Maze, Radial Maze) but also could be configured for any behavioral measurement using mobile device.
- Automation of animal behavior data acquisition and analysis: interface with existing systems such as Observer and Videotrack.
- Definition and maintenance of Activity Base template and reports.
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ADESIUM
- Consultant SI
Pont salomon
2001 - 2003
Au sein d'un centre de recherche d'un laboratoire pharmaceutique (Aventis Pharma Vitry Alfortville) :
- Automatiser et optimiser le traitement de données expérimentales
- Assister au choix de systèmes d'acquisition
- Développer un programme d'acquisition (sur pocketPC) et de traitement de données comportementales (tests de cognition : Object recognition, Radial Arm Maze, T-Maze, etc)
- Enregistrer et archiver des résultats dans ActivityBase, créer des rapports sous Intranet
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MANPOWER and RATP
- Technical Assistance
1998 - 2001
UNILOG - PARIS
For MANPOWER Training Department - Paris
- Discrepancy and change management ;
- Testing strategy definition and tests execution coordination
- Test script definition and execution using an in-house test automation system
- User requirements analysis and formalization ;
- Testing of a e-learning GMP software used to train interim employees
For RATP (Parisian subway)- Paris & Noisy Le Grand
- Development of a ticketing system used by RATP with strong performance and ergonomic requirements (up to 10,000
incidents/day)
- Coordination of the CMMS data warehouse development ;
- Inventory management and billing system maintenance ;
- Management of change and corrective maintenance, definition of the Quality Assurance Plan ;
- Development of an interface between a Bus renting system and ERP (Oracle Application)
Training department Paris (France)
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UNILOG
- Consultant SI
1998 - 2001
Développeur puis chargé du suivi de la TMA et de la garantie d'un système de gestion des anomalies (maintenance) pour le compte de la RATP
Responsable de la validation d'outils de formation pour le compte de MANPOWER
