Ellen Van Vijnckt

Deputy Head of Medical Evidence Operations/ Global Study Manager at Roche BeLux
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Location
Zulte, Flemish Region, Belgium, BE

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Experience

    • France
    • Real Estate
    • Deputy Head of Medical Evidence Operations/ Global Study Manager
      • May 2020 - Present

    • Switzerland
    • Biotechnology Research
    • 700 & Above Employee
    • Head Start Up&Admin Team Country Clinical Operations
      • Feb 2018 - Apr 2020

      Leading team of 6 people in Swiss affiliate. Department is responsible for start-up phase of Roche 's global studies in Switzerland (all indications, phases etc.). Main tasks include line management, resourcing, budget ownership/management, leading and participating in work streams after reorganisation in order to create new SOPs,...

    • Vendor Manager Country Clinical Operations
      • Feb 2017 - Jan 2018

    • Senior Clinical Research Associate
      • Sep 2014 - Apr 2016

    • Lead Clinical Research Associate
      • Sep 2014 - Mar 2016

      After relocation to Switzerland I was asked as a Senior and Lead CRA in a new team of CRAs. Responsible for clinical trials from phase 1 to phase III, this from start up until closure.As lead for a new team, and in absence of a team manager, I was responsible for organising weekly team meetings, training of junior CRAs (1 on 1, organisation and leading group training days, developing tools and aids). After relocation to Switzerland I was asked as a Senior and Lead CRA in a new team of CRAs. Responsible for clinical trials from phase 1 to phase III, this from start up until closure.As lead for a new team, and in absence of a team manager, I was responsible for organising weekly team meetings, training of junior CRAs (1 on 1, organisation and leading group training days, developing tools and aids).

    • Senior Clinical Research Associate and Clinical Project Manager
      • Apr 2013 - Oct 2014

      CRA for clinical trials from phase III to V in several domains s.a. oncology (metastatic melanoma, mCRC, breast CA) and rheumatoid arthritis.Responsible from start up until clinical closure with excellent knowledge of ICH GCP. This in good contact with site staff, physicians, Authorities and Ethic Committees.Also introducing and training of junior CRAs into the job.As CPM responsible for financial planning and granting resources, leading/organising meetings between different parties involved.

    • Clinical Research Associate
      • Sep 2011 - Mar 2013

      CRA for clinical trials from phase III to V in several domains s.a. oncology (metastatic melanoma, mCRC, breast CA) and rheumatoid arthritis.Responsible from start up until clinical closure with excellent knowledge of ICH GCP. This in good contact with site staff, physicians, Authorities and Ethic Committees.

    • Belgium
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Research Nurse
      • Jun 2010 - Sep 2011

      Clinical Research Nurse for Urology and Gynaecology.Conducting all operational, admin, and logistical tasks which are required. Clinical Research Nurse for Urology and Gynaecology.Conducting all operational, admin, and logistical tasks which are required.

    • Canada
    • Information Services
    • Compliance/Educational Nurse
      • Sep 2009 - Jun 2010

      Temporary assignment as a compliance nurse working with GPs and their patients across Belgium. Main task was to educate patients to accomplish a higher compliance in correct medication intake. Temporary assignment as a compliance nurse working with GPs and their patients across Belgium. Main task was to educate patients to accomplish a higher compliance in correct medication intake.

    • Human Resources
    • Midwife/ Nurse
      • Jul 2007 - Sep 2009

      Midwife/Nurse working at several wards (s.a. ER, Intensive Care Unit, Neonatal Intensive Care Unit, Paediatric Ward, Gynaecology) in different hospitals in Ghent. Midwife/Nurse working at several wards (s.a. ER, Intensive Care Unit, Neonatal Intensive Care Unit, Paediatric Ward, Gynaecology) in different hospitals in Ghent.

    • Belgium
    • Hospitals and Health Care
    • 500 - 600 Employee
    • Midwife
      • Jan 2007 - Jun 2007

      Midwife working on maternity and neonatology ward. Midwife working on maternity and neonatology ward.

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