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Maggy CHAUSSON

MONTROUGE

En résumé

• 10 years’ experience in clinical studies
• International and National multicentric studies phase II to IV
• Therapeutic experience in oncology, respiratory, neurology, cardiology, urinary
• Activities: budget management, submission (EC, CA, CNOM, CNOI), development/translation/review of study documents (consent forms, protocol summary…), interactions with study team (CRAs, CTAs, GTM, regulatory affairs and pharmacovigilance departments…), realisation of co-visits, monitoring and close out visits.


Mes compétences :
Chef de projet
Études cliniques
Respiratory System
Pharmacovigilance
Oncology
Neurology
Cardiology
Budget management
base management
Urology
Therapeutic experience
Leukemia
Kidney transplant
ICH
Epidemiology
Clinical Trials
COPD
Breast Cancer
Asthma

Entreprises

  • GSK outsourcing by Docs Global - Country StudyManager,

    2014 - 2016 Trials in phase III in respiratory (COPD, asthma)
    * Budget management ;
    * Managing CRAs, CTAs
    * Realisation of co-visits
    * Review and validation of visit reports ;
    * Interaction with international study team, regulatory affairs and pharmacovigilance departments ;
    * Negotiation/realisation of contracts with investigators, CRAs and study nurses

  • Novartis outsourcing by Docs Global - Local project leader

    2013 - 2014 Medical follow up of trials in phase III, IV and observational in renal transplantation
    * Support the Medical Adviser ;
    * Coordinate the clinical activities with the internal and/or external teams (data manager, biostatistician, project manager, CRAs..) ;
    * Realisation of the documents necessary for submission to the EC ;
    * Contribute to the realisation of the clinical report

  • Janssen-Cilag outsourcing by Docs Global - Clinical trial coordinator

    2012 - 2012 Trials in phase II and III in lymphomas
     Realisation of regulatory submission (EC and CA)
     Preparation of budget (national and per site)
     Managing CRAs
     Realisation of co-visits (pre-study and initiation)
     Review and validation of visit reports

  • Harrison Clinical Research - Senior Clinical Research Associate

    2009 - 2011 Senior Clinical Research Associate with activities of coordination since August 09, Harrison Clinical Research,
    Follow up of trials in phase II and III in various therapeutic area: leukaemia, neurology, breast cancer and urology
    * Conducting of all trials in compliance with ICH/GCP and regulatory requirement ;
    * Conducting of pre-study, initiation, monitoring and closure visits ;
    * Realisation of regular reporting to the internal project manager ;
    * Realisation of regulatory submission (EC, CA, CNOM....) ;
    * Negotiation and writing contracts ;
    * Managing CTAs and CRAs

  • Hospital Cochin and INSERM - Senior Clinical Research Associate

    2005 - 2008 Follow up of trials in oncology (phase III) and in cardiology (phase IV epidemiology)
    * Writing CRF ;
    * Conducting of initiation and monitoring visits ;
    * Phone contacts with patients
    * Access data base management ;
    * Training /managing CRAs

Formations

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