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Estelle LE MOAL-ROUX

RUEIL MALMAISON

En résumé

Mes compétences :
Gestion de projet
Management
R&D

Entreprises

  • Novartis - Clinical Trial Budget Manager - Oncology Global Development

    RUEIL MALMAISON 2016 - maintenant Responsible for the budget management of 2 clinical programs:
    - Over 20 Global clinical studies with study lifetime budgets ranging from $750k to $65m (total portfolio budget $210m)
    - Manage financial requirements of clinical program budget by providing consolidated latest estimates on current year budget and future year planning budget.
    - Identify issues and propose mitigating plans for facilitating decision making.
    - Challenge and track program/trial timelines, resource requirements and expenditures and initiate adjustments as needed.
    - Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning.
    - Ensure budgets remain in line with internal benchmarks and historical spending data.
    - Provide clinical trial process and budget training to clinical staff.
  • BIO-RAD - Project Manager (PMO)

    Marnes La Coquette 2010 - maintenant Management of Multi-projects (portfolio of up to 8 projects) in the medical diagnostic area.
    · Large scale of project types: regulatory implementation (accreditation, labeling), defining and
    implementation of the new division strategy, manufacturing transfer, registration process (CE mark,
    Health Canada, FDA) and new product development projects.
    · Managing US clinical evaluations (FDA) and 510k submissions/clearance through internal or
    external partners (clinical budget 200k$ - 800k$).
    · Coordination of cross-functional teams: R&D, marketing, manufacturing, regulatory and clinical
    affairs, quality assurance, patent, legal partners in France, Europe and US.
    · Monitoring of project scope, delay and cost to ensure project completion on schedule using MS
    project. Set up regular projects review meetings with core teams, stakeholders and/or external
    partners.
    · Collect deliverables and implement the project design history files, risk identification and definition of
    mitigation plans.
    · Ensure compliance to quality system, regulatory procedures, and design controls. Good
    knowledge of FDA 21CFR & GMP, ISO 13485 / 14971 / 15189 / 21500 and CLSI recommendations
    under strong regulation and legal constraints (FCPA, sunshine Act …).
  • Bio-Rad - R&D project manager

    Marnes La Coquette 2007 - 2010 Significant success for developing and launching a new HIV Combo diagnostic kit, qualitative
    immune-assay for the combined detection of HIV Ag and Ab anti-HIV to run on multi-automations
    (Access, Beckman Coulter).
    · Management of four technicians and one project leader assistant.
    · Coordination of the project, planning monitoring to meet deadlines
    · Cross-functional collaboration with patent, legal, transfer platform and quality department
    (regulatory and clinical), Hospitals and Blood Banks.
    · Scientific survey: bibliography and congress attendance.
  • Bio-Rad - R&D project manager assistant

    Marnes La Coquette 2004 - 2006 Development of new innovative diagnostic tools (ELISA) for cardiac diseases.
    · Multi-analyte study to help the stratification of cardiovascular diseases: Identification and validation
    of new biomarkers after development of ELISA testing.
    · Clinical study protocol redaction with ethic comity validation and monitoring of the serum bank.
    Collaborations University Hospital of Nîmes (Dr Bertinchant, 2004-2005).
    Veterian Hospital of San Diego (Nov. 2006)

Formations

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