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Hélène LAUR

Paris

Electionsmunicipales 2026

RETROUVEZ GRATUITEMENTRésultat de la municipale à Paris

En résumé

Mes compétences :
Recherche clinique

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Entreprises

  • Sanofi - Clinical Trial Operations Manager (Diabetes) - HAYS

    Paris 2013 - maintenant Since july 2014
    Phase IIIb - Type2 Diabetes - set-up (19 countries)
    Conduct of study set-up activities:
    - Budget: planning and monitoring
    - Development of study plans (recruitment, monitoring, data management, risk) and study documents (training, device user manual)
    - Selection and management of external providers: data management, e-diary, IVRS, central laboratory
    - Trial management: Coordination of sites initiation of 190 sites

    Implementation of an e-diary adapted to elderly population:
    - Design and data flow: data collection in e-diary, view in vendor’s portal, transfer in clinical database
    - Supply strategy: Development of the distribution plan. Coordination of the implementation with local contacts according to local regulation

    Transversal activities:
    - Close collaboration with purchasing, e-CoA/e-PRO manager and e-diary provider to improve the implementation of an e-diary in Diabetes studies: reporting of issues and risks identified with action plans implemented and/or new proposal.

    june 2013 - june 2014
    Phase III - Type2 Diabetes - DB lock (13 countries)
    Trial Management on 2 similar studies with 1 interim and 2 final DB lock in 6 months. Responsible for the coordination of end of study activities until site close-out procedures.
    Data cleaning: Review of validation listings and control of missing data. Involved in the data review and surveillance in collaboration with Biostatistics department.

    Transversal activities at program level (7 studies):
    Review board management:
    - Leader for operational activities related to the review of hypoglycemic events.
    - Communication with the members of the board including the planning of the review according to study timelines.
    - Coordination of activities from the preparation of dossier submitted to the committee to the validation of data entered in the clinical database.

    PAI readiness:
    - Review of study documents / process (FDF, FDA1572 submission, training, etc)
    - Preparation of documentation for the Clinical Study Report, and for audit and inspection in collaboration with Quality Assurance and Medical writing.

  • Sanofi - Clinical Trial Operations Manager (Mega-trial-thrombosis) - HAYS

    Paris 2012 - 2013

  • Sanofi - Clinical Trial Operations Manager trainee (Mega-trial, thrombosis)

    Paris 2011 - 2012

  • Centre CAP - Clinical Research Associate trainee (phase I, CRO)

    2011 - 2011

Formations

Réseau

Annuaire des membres :