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Laura González RosalesLG

Laura González Rosales

Clinical Trials|MDR|EU project|Statistics

EUR 350/Tag
Barcelona, ES
15+ Jahre

Durchschnittliche Reaktionszeit: 1h

Über Laura

I am a highly organized Clincial Research Coordinator & Project Manager with extensive experience in clinical trials and research projects. I have coordinated over 100 studies, including Horizon Europe and H2020 consortia, and bring strong expertise in managing workflows from start to finish.
I can cover project tracking, deadline follow-up, data cleaning and organization, biostatistical analysis (SPSS, R, Jamovi, JASP, excel), preparation of protocols, IRB forms, SOPs, databses (sharepoint, redcap, openclínica), datasets, tables, and appendices, manuscript formatting and submission to peer‑reviewed journals, and clear documentation with version control. I also provide regular updates and proactive solutions to delays.
My background is Master’s in Clinical Trial Monitoring, ongoing Master’s in Biostatistics, deep knowledge of regulatory frameworks (EMA, MDR, GCP), and hands‑on experience in clinical trial operations (phases I–III). I am also certified by BSI group in technical docummentation in MDR. Experienced in writing clinical trial protocols and clinical investigation plan, using mendeley, zotero, and good results in obtaining EECC, possitive opinion
Excellent English writing and communication, highly reliable, independent, and detail‑oriented.
I am available 10–20 hours per week depending on project volume.
As my professional background is head of R&D in a Spanish company with more than 20 clinics performing clinical trials simoultaneously over the years, I have trained myself to work across several projects simultaneously, turning complexity into structured workflows and reliable outcomes and enjoying in the process
  • Englisch

    Verhandlungssicher

  • Spanisch

    Muttersprachlich oder zweisprachig

  • Katalanisch

    Muttersprachlich oder zweisprachig

Vor Ort möglich
Barcelona (bis zu 50 km)

Projekt- und Berufserfahrung

  • Presentia Research
    Freelance Consultant
    Januar 2025 - Heute (1 Jahr und 5 Monate)
    Barcelona, Spanien
    Clinical and regulatory project management in more than 70 studies, including multicenter trials and European consortia. Expert in regulatory affairs, MDR, REDCap, SPSS, and data‑flow automation. Founder of Presentia Research and independent consultant.
    Proyectos Europeos Clinical Trial Lifecycle Medical Device IBM SPSS SOP
  • Instituto de Microcirugía Ocular
    Director of R&D
    Januar 2002 - Januar 2025 (23 Jahre)
    Progressed from optometrist to Director of R&D. Led over 70 clinical and translational research projects, coordinated European consortia, and managed regulatory documentation for medical devices and drug trials.

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Ausbildung und Abschlüsse

  • Master's degree in biostatistics
    Universidad Miguel de Cervantes
    Bioestadística
  • MDR Technical Documentation
    BSI
    2025
    MDR Technical Documentation

Fähigkeiten

Kategorien

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