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Valerie GOMBAU DELAVOIPIERRE

PARIS

En résumé

Mes compétences :
Clinical Operations
Rheumatology
Cardiology
coordinate planning and implementation
contract negotiation
budgets
Responsible for the budget
Responsible for subcontractor identification
Responsible for harmonization
Responsible for budgets
Project Management
Profit and Loss Accounts
Oncology
New operational structures implementation and deve
Microsoft Visio
Microsoft Publisher
Microsoft Project
Microsoft Office
Manage multi
ISO 900X Standard
IS Quality management
Human resources
Human Resources Management
Financial management
Epidemiology
Endocrinology
Employment Law
Diabetes
Clintrial
Clinical Trials
Business Objects
Business Development Management
Audit
Administration

Entreprises

  • CERC-Cardiovascular European Research Centre - General Manager

    2012 - 2016

  • NORDIC PHARMA - Head of Clinical Operations

    2012 - 2012 * Main activities and responsibilities Accountable for the set-up of a clinical operations department and its management
    Overseeing clinical trials conducted by the department

  • LA-SER Group - Chief Operating Officer

    2009 - 2011 * Type of business or sector CRO with expertise in Pharmaco-epidemiology and Market access ;
    * Occupation or position held Chief Operating Officer ;
    * Main activities and responsibilities Accountable for the International Operation activities ;
    * Ensure that the projects are set-up and conducted in accordance with budget,
    timelines and quality standards
    * Responsible for resources management and forecast within the department
    * International line management of CRAs, Project Managers, Quality Manager, Project
    Associates
    * Responsible for the budget allocated to the Operations department (several EUR M
    annualy)
    * Responsible for subcontractor identification, contract negotiation and deliverables
    assessment
    * In charge of the company development in opening new countries/offices/structures
    * Involved and contribute to strategic business development
    * Present in bid defence meetings

  • PHASE FORWARD - International Senior Project Manager

    2007 - 2009 * Main activities and responsibilities Responsibility for effective international project management e-Process solutions to agreed
    timelines, budgets and quality standards to ensure high levels of customer satisfaction.

    * Organize, direct, and coordinate planning and implementation of all contracted project
    activities and provide guidance to customer on the best practices for implementing e-
    Process solutions.
    * Manage multi-discipline teams of internal & external resources.
    * Responsible for the technical and business quality of engagement work products,
    solutions, and deliverables.
    * Track and communicate project status, plans, issues, timelines, action items
    * Responsible for budgets monitoring

  • SERVIER Laboratories - Clinical Studies Support Manager

    2004 - 2007 * Main activities and responsibilities * Responsible for harmonization of the working organization between international
    structures at the worldwide clinical operations level
    * Provide expertise to clinical operations (CO) ;
    * Training and coaching of CRA (Servier & CRO) ;
    * Improvement of the monitoring techniques ;
    * Propose evolution of the requirements and the standards
    * Participate in study documents finalization (protocol, CRF, monitoring guide)
    * Management of the international medical review teams ;
    * Provide support for logistical aspects (set-up of trials) ;
    * EDC expect for CO

    Propose new company process and organization
    Trainer on the EDC tool (InForm) for company staff, CRO, and investigational centres
    * IT systems expert
    Trainer on the IT tools (EC1, Business Object, Documentum)
    Relay for the CO users

  • SERVIER Laboratories - Clinical Trials Manager

    2000 - 2004 * Monitoring of international trials
    Phase III in cardiology, rheumatology and endocrinology
    From Site initiation to closure
    * Participate in investigator meeting ;
    * Financial management of the study as delegated by the PM ;
    * Able to deal with different regulatory environments ;
    * CRF Medical review
    Data quality controls with ``Clintrial'' software
    * Audit preparation

Formations

Réseau

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