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Gérald NEVEU

Paris

En résumé

With a background as a biologist in molecular genetics, I develop a strong experience in data management in pharmaceutical and food industries. After 6 years as a Study Team Leader and Project Manager, I’m now managing the operational activities on the clinical data management platform for two out of the 5 divisions of Danone with the objectives to enlarge the data management perspectives by improving process, maintaining partnership and developing new solutions to exploit the data from Danone’s legacy and optimize data management flow.
In parallel, I help to develop a Global Data Strategy for the Dairy division defining the best way to enhance the data use in their whole lifecycle.

Mes compétences :
Data Manager
SAS
Oncologie
PL/SQL
Recherche clinique
EDC Selection and implementation
Visual Basic
CDISC (SDTM/SEND)
Medidata Rave
Formedix

Entreprises

  • Sanofi

    Paris maintenant

  • Danone Nutricia Research - Senior Data Manager/Data Analyst

    2015 - maintenant - Operational Team Leader for Clinical Data Management activities
    => Reinforce team involvement, motivation and communcation, Team working homogeneization
    => Coordinate activities on QMS, Clinical Studies and WoW implementation
    => Main contact with all partners (eCRF/ePRO providers, Study Builder, CDISC Mapper, CRO)
    => Maintain a constant innovation on WoW and develop his efficiency
    => Global Budget, Timelines and ressources management for Clinical Studies
    => Data and Metadata repository administrator

    - Data Analyst
    => Global data strategy deployment
    => Participation to the development of a R&D Big Data platform
    => Development of tool based on Agile methodology (Use Case / User stories definition)

  • Aixial - Clinical Project Data Manager/Data Analyst

    Levallois-Perret 2011 - 2014 Contractor for Danone Research
    - I - Clinical Project Data Manager
    o Management of preclinical, clinical and data mining projects
    CRF paper form-eCRF/Formedix ORIGIN/Medidata Rave/Open Clinica/SAS 9.2/XML4PHARMA
     EDC selection, Rave implementation (Core Configuration/ Danone Group owner)
     Conferences speaker (EDC - CDISC/ODM implemtation)
     SDTM Database mapping (Based on a SDTM-ETL tool)
     Setup of eCRF process (ODM, Metadata Repository, Procedures, CDISC mapping, Data Warehouse, Data Visualization Tool)
     Management of data pooling for Meta-analysis (Regulations purposes)
     CRO management and coordination on clinical projects
     Data Management expertise for WorldWide epidemiologic study launch
     Management of contract, feasibility, planning and budget (Clinical studies)
     Setup of process for preclinical studies
     Data Repository administration
     Creation, merging and management of internal databases (SAS)

  • Umanis Clinical Research - Clinical Trial Operations Manager

    Levallois-Perret 2009 - 2011 Contractor for Sanofi-aventis
    - I - Clinical Trial Operations Manager (July 2009-June 2011)
    o PK management for 6 studies and study leading (Phase I/II/III – Oncology)
    eCRF/OC-RDC 4.5.3/SAS 9.2
    => International team leader (2-10 partners) on 2 phase III studies
    => Main contact between the 2 sponsors for PK project management (timelines, coordination of activities : shipment, analysis)
    => Setup process and management of PK reconciliation for 6 studies
    => Coordination/communication with monitoring team
    => Working group participation (Tools and process improvement)
    => Team meeting participation (Data/medical review, CRU/Clinical team meeting)
    => Contact with biostatistician, Clinical Study Director, pharmacovigilance and coding
    => Patient Profile Review – CIOMS
    => SAS programming

  • Umanis Clinical Research - Data Manager

    Levallois-Perret 2006 - 2009 Contractor for Sanofi-aventis
    - I - Clinical Data Manager (December 2006 – June 2009)
    o Setup and closure of a project of 3 studies (Phase III – Psychiatry/Insomnia)
    CRF paper form/Clintrial 4.3/SAS 8.2
    => Databases design (Structure – Study Book)
    => Redaction of clinical data management documents
    => CRO management (Central laboratory, IVRS, data entry)
    => PL/SQL programming and validation of edit checks
    => CRA training on new procedures and tools

  • Sanofi-Aventis - Assistant de recherche en génétique moléculaire

    Paris 2002 - 2006 - I - Research assistant in molecular genetics and genomics
    => QPCR-Taqman® platform setup.
    => Research on quantitative genetic variation in karyotypes of human cancer cell lines.
    => Projects supervising and management of QPCR-SybRGreen® platform
    => Research for functional mutation on human cancer cell lines.
    => Research for target genes responsible for Schizophrenia and Alzheimer disease.

Formations

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