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Carole CATHELINEAU

ASNIERES SUR SEINE

En résumé

I am 10-years experienced in clinical research with extensive knowledge of CRO and laboratory environment. I have been managing a large team of CRAs, CTAs and SSUAs across Europe, being the head of ClinOps in France. In addition, I have been leading several studies as Project Manager, on operational and financial perspectives.

My experiences in CROs give me the full picture on study management, from contract award to final study report and make me able to deal with client relationship, business strategy and cost/performance matters.

Mes compétences :
Animation de formations
Formation
Management
Industrie pharmaceutique
Communication
Audit
Négociation contrats
Gestion des ressources
Oncologie
Suivi financier
Developpement procédures et outils
Management des risques
Prévision, planification

Entreprises

  • Premier-Research - Clinical Research Manager

    2011 - 2017 Manager of up to 20 CRAs, CTAs and SSUAs in France, Belgium and Netherlands on both pharmaceutical and device studies (phases I to III). Project manager of several studies for various Sponsors, in oncology, vaccines and medical device.

    Clinical Operations Management – Country leader for ClinOps France
    - Resource planning and allocation – utilization target of 95%
    - Metrics and tracking tools review
    - Team trainings and accompanied visits; team building
    - Monitoring activities progress & reporting to senior management
    - Reports review
    - Review of company SOPs
    - Audit preparation and office audits host – CAPA follow-up
    - Assessment of performance / hiring / annual appraisals

    Project Management – French & US clients
    - Financial follow-up and budget review
    - Scope of work review
    - Key Performance Indicator review
    - Change order negotiation
    - Primary contact with client
    - Invoicing, revenue expectation, PTCs
    - Proposals & BID Defense meetings

  • Quintiles - Attachée de Recherche Clinique Senior

    Durham 2007 - 2011 Full monitoring activities (from feasibility to close-out visits) for Phases II to IV international studies in accordance with GCPs, local regulation and applicable SOPs

    - Efficient direct communication with the sponsor in an international landscape
    - Management of more than 20 studies / up to 9 studies at the same time
    - eCRF, IWRS, CTMS, central lab, central imaging vendor, data entry technician
    - Expert of Oracle Clinical eCRF
    - Mentoring of Junior CRAs
    - Risk-based monitoring

  • Laboratoires Dermatologiques d'Uriage - Attachée de Recherche Clinique

    Courbevoie 2006 - 2006 Key partner of Research & Development unit, marketing team and medical Director - Management of Clinical studies, Surveys, Consumers tests and instrumental measurements

    - Organization of tests in accordance with marketing needs and budget management
    - Selection and supervision of vendors
    - Submission to Ethics Committee
    - Set up and monitoring of a clinical study
    - Creation of publications and posters

  • Eurosyn Développement - Assistante chef de projet

    2005 - 2005 Management of two consumer tests on a cosmetic product :
    - Choice of panelists
    - Management of cosmpetic products : Supply, labelling
    - Organization of training meetings
    - Study and panelists follow-up
    - Management of data and results analyses
    - Report writting in english

  • Technologie SERVIER - Technicienne de laboratoire

    2003 - 2003 Initiation of a dissolution chain :
    - Installation of the equipment
    - Qualification of the material and comparison with existing materials on a comparator product
    - Results analyses
    - Training to staff

Formations

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