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Agnès Crespy MaloneyAC

Agnès Crespy Maloney

Senior Clinical Project Manager, GCP Auditor

€900/day
Montpellier, FR
15+ years

Average response time: 1 hour

Freelancer profile translated to English.
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About Agnès

-> Senior Clinical Project Manager with over 15 years of experience in the pharmaceutical industry and international clinical research. I have managed Phase I to III studies in oncology, neurology, rare diseases, vaccines, and medical devices within GSK, Syneos Health, IQVIA Biotech, and UCB.

Expert in global clinical project management, CRO and vendor coordination, risk management, budgets, and regulatory compliance, I support teams in the operational success of their studies.

Recently graduated with a DU in Quality Audit in the Pharmaceutical Industry, I also offer GCP audit missions, inspection readiness, quality system improvements, and regulatory compliance support.

Pragmatic and results-oriented, I work with pharmaceutical laboratories, biotechs, CROs, and investigative centers in France and internationally.
  • 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 Internal Audit
  • 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 Pharmaceutical Industry GxP Auditor
    Faculté Pharmacie Paris Cité
    Auditor Diploma
  • Certification Audit - ISO 9001:2015
    Institut Godinot
    2026
    ISO 9001:2015

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