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Ayelen GallardoAG

Ayelen Gallardo

Clinical Program Lead Consult |Agile coach | PCC

€750/day
La Ciotat, FR
8-15 years

Average response time: 1 hour

About Ayelen

I am a Clinical Program Consultant and ICF PCC certified Coach with 8+ years of experience managing complex clinical projects across Life Sciences, Digital Health, and MedTech.
My expertise sits at the intersection of clinical operations, transversal project coordination, and organizational transformation. I specialize in ISR, CRS, and RWE studies — projects that require more than execution: scope definition in ambiguous environments, multi-stakeholder coordination without hierarchical authority, regulatory compliance (ICH GCP, MDR 2017/745), and change management.
As a certified Agile Coach, I bring iterative and adaptive approaches to clinical teams navigating complexity, new tools, and organizational change.
As a PCC Coach, I support executives, managers, and teams through professional transitions and leadership development.
I work 100% remotely and serve clients in France, Spain, and Latin America — in French, English, and Spanish.
What I bring: structure where there is chaos · alignment where there is fragmentation · delivery where there is uncertainty.
  • French

    Native or bilingual

  • Spanish

    Native or bilingual

  • English

    Fluent

Remote only
Primarily works remotely

Experience

  • Ausare
    PCC Coach — Ausare / Coaching Ways France
    July 2024 - Today (1 year and 11 months)
    ICF PCC certified professional coach. Accompanying executives, managers and teams through professional transitions and leadership development. Resource coach on certified training programs.
    Executive Coaching Leadership Change Management Agile method
  • FeetMe
    Life Sciences Program Lead
    July 2022 - July 2024 (2 years)
    Led and developed a multidisciplinary team of clinical project managers. Oversaw 20+ interventional and non-interventional international studies (Parkinson's, Alzheimer's, MS, diabetes). Coordinated pharma sponsors, academic and hospital partners. Designed and implemented project management processes and tools. Full regulatory compliance under EU MDR for medical devices.
  • FeetMe
    Clinical Project Manager
    June 2021 - July 2022 (1 year and 1 month)
    France
    Managed complex multi-site, multi-country clinical projects. Cross-functional coordination across R&D, quality, and external partners. Budget and risk management. Contributed to medical device certifications through successful clinical data submissions.

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Education

  • (TOIEC & First Certificate
    (TOIEC & First Certificate
  • SaaS Healthcare & Digital Adoption MD Certification (Class I, Ila) GCP/ICH, MDR & FDA Regulations
    SaaS Healthcare & Digital Adoption MD Certification (Class I, Ila) GCP/ICH, MDR & FDA Regulations

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