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Agnès Crespy MaloneyAC

Agnès Crespy Maloney

Senior Clinical Project Manager, Auditor GCP

€900/day
Montpellier, FR
15+ years

Average response time: 1 hour

About Agnès

-> Senior Clinical Project Manager avec plus de 15 ans d'expérience dans l'industrie pharmaceutique et la recherche clinique internationale. J'ai piloté des études de phase I à III en oncologie, neurologie, maladies rares, vaccins et dispositifs médicaux au sein de GSK, Syneos Health, IQVIA Biotech et UCB.

Experte en gestion de projets cliniques globaux, coordination de CROs et fournisseurs, gestion des risques, budgets et conformité réglementaire, j'accompagne les équipes dans la réussite opérationnelle de leurs études.

Récemment diplômée d'un DU d'Audit Qualité dans l'Industrie Pharmaceutique, je propose également des missions d'audit GCP, d'inspection readiness, d'amélioration des systèmes qualité et d'accompagnement à la conformité réglementaire.

Pragmatique et orientée résultats, j'interviens auprès des laboratoires pharmaceutiques, biotechs, CROs et centres investigateurs en France et à l'international.
  • English

    Native or bilingual

  • French

    Native or bilingual

Can work on-site
Montpellier (up to 50km), Lyon (up to 50km), Paris (up to 50km), Marseille (up to 50km), Toulouse (up to 50km)

Experience

  • Astra-Zeneca
    Senior Clinical Project Manager
    PHARMACEUTICALS INDUSTRY
    January 2026 - May 2026 (4 months)
    Amsterdam, Netherlands
    • • Led quality oversight activities for global Phase I–III clinical trials in compliance with ICH-GCP and applicable regulatory requirements.
    • • Performed vendor qualification and oversight activities for CROs and external service providers.
    ICH GCP Audit interne
  • UCB Pharma S.A.
    Senior Clinical Project Manager
    PHARMACEUTICALS INDUSTRY
    November 2020 - February 2025 (4 years and 3 months)
    • • Led quality oversight activities for global Phase I–III clinical trials in compliance with ICH-GCP and applicable regulatory requirements.
    • • Performed vendor qualification and oversight activities for CROs and external service providers.



  • IQVIA Biotech
    Senior Clinical Project Manager
    June 2019 - November 2020 (1 year and 5 months)
    • • Oversaw international clinical development projects ensuring compliance with ICH-GCP requirements.
    • • Managed qualification, selection and oversight of CROs, laboratories and clinical vendors.
    • • Conducted risk-based quality assessments and vendor performance reviews.
    • • Ensured implementation of corrective and preventive actions (CAPAs).
    • • Contributed to quality management and governance processes across multiple studies.

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Education

  • Auditor Diploma - DU Auditeur GxP Industrie Pharmaceutique
    Faculté Pharmacie Paris Cité
    Auditor Diploma
  • Audit de Certification - ISO 9001:2015
    Institut Godinot
    2026
    ISO 9001:2015

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