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Su Zhang

Su Zhang

Tolk

Followers of Su Zhang756 followers
location of Su ZhangMalmo, Skåne County, Sweden

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  • Timeline

  • About me

    Wellspect HealthCare - Clinical Evaluation Manager

  • Education

    • Peking University

      2001 - 2006
      Bachelor's Degree Medicine with direction of public health

    • Karolinska institutet

      -
      Kunskapsprov för Läkare med Utländsk Examen Medicinsk kunskapsprov Godkänd

    • Lund University

      2007 - 2012
      Doctor of Philosophy (Ph.D.) Adhesive and signaling mechanisms in abdominal sepsis

    • Malmö University

      2013 - 2014
      Behörighetsgivande utbildning i svenska

  • Experience

    • CarpoNovum AB

      Aug 2010 - Nov 2011
      Tolk

      Deltidstjänst som tolk och var ansvarig för att förmedla och underlätta informationsflöde, kontakta sjukhus och myndigheter i Kina, översätta dokument av kliniska studier.

    • Region Skåne

      Jun 2012 - May 2013
      Assistant Researcher

      Research of septic lung injury and T-cell function in abdominal sepsis

    • Lund University

      Jun 2013 - Mar 2015
      Laboratory Researcher

      Research on mechanisms of inflammation in abdominal sepsis with focus on plasma microparticles, neutrophil extracellular traps (NETs) and coagulation process.

    • SuZ Consulting

      Jan 2015 - Sept 2020
      Owner

    • CarpoNovum AB

      Apr 2015 - Aug 2020

      Development, review and edit of documents for medical device clinical trials, including CIP, IB, CRF, ICF and other essential documents. Interpretation and analysis of clinical trial results, including data analysis, composition of Clinical Study Reports (CSR) and publications on scientific journals.Evaluation of clinical data and composition of Clinical Evaluation Report (CER) for CE marking of medical devices.Facilitate negotiation of site Clinical Trial Agreements (CTA) Regulatory compliance assistance of medical device registration in China Food and Drug Administration (CFDA).Supplier control according to ISO 13485, including in-site supplier audit.Analysis of pre-clinical study data and composition of publications on scientific journals.Technical translation. Show less Main tasks:Development, review and edit of documents for medical device clinical trials, including CIP, IB, CRF, ICF and other essential documents. Design and development of eCRF system.Implementation of clinical trials, including EC submission, ISF and TMF document management, in-site and remote monitoring, query solution, site communication, study close-out etc. Interpretation and analysis of clinical trial results, including data analysis, composition of Clinical Study Reports (CSR) and publications on scientific journals.Facilitate negotiation of site Clinical Trial Agreements (CTA) Other tasks:Composition of products Instructions For Use (IFU).Regulatory compliance assistance of medical device registration in China Food and Drug Administration (CFDA).Medical device sterilization validation.Analysis of pre-clinical study data and composition of publications on scientific journals.Non-confirming and CAPA.Technical translation. Show less

      • Clinical Research Manager

        Jun 2018 - Aug 2020

      • Clinical Trial Advisor

        Apr 2015 - May 2018

    • KEY2COMPLIANCE® - Rely on us

      Sept 2020 - Jun 2021
      Senior consultant Clinical Evaluation

      Working with clinical evaluations of medical devices, clinical investigations and medical writing.

    • Ambu A/S

      Jul 2021 - Aug 2022
      Clinical Research Specialist

    • Wellspect HealthCare

      Aug 2022 - now
      Clinical Evaluation Manager

  • Licenses & Certifications

    • Intyg om kunskaper i svenska för studenter med utländsk förutbildning

      Malmö University
      Jan 2013

    • Bachelor's Degree of Medicine

      Peking University
      Jul 2006

    • Doctor of Philosophy in Medical Science

      Lund University
      May 2012

  • Honors & Awards

    • Awarded to Su Zhang
      Chinese Government Award For Outstanding Self-financed Student Abroad China Scholarship Concil 2011