BrightOwl Loader Loading

Experiences

Current Experience

  • Clinical Research Associate (CRA)

    Mechelen, Belgium
    Since June 2015

Past Experience

  • Clinical Data Manager (DM) Mechelen, Belgium

    June 2013 --- June 2015

    lead clinical data manger of multiple early phase Clinical trials:
    Data Management set-up activities: review eCRF/sample crf (esource), review eCRF completion guidelines, perform uat of the edc tool, develop and maintain Data Management plan.
    • database Validation: review annotated crf and validate conversion of Clinical Trial data to high quality, reliable, and statistically sound data in sponsor desired (sdtm) format.
    • data review: create data Validation plan listing all electronic and manual rules used in the data review process; define and validate new electronic rules when needed; clean clinical data and detect science)" rel="nofollow">Protocol deviations using the data Validation plan; create and maintain data handling report describing all unsolved issues/decisions taken during Data cleaning activities.
    • work closely with the sponsor, clinical site(s) and Statistical department in order to coordinate all activities related to the Data Management of Clinical trials.

    additional role (march 2014 - june 2015): subject matter Expert labpas (esource):
    • be single point of contact for people with subject-related issues and questions
    • train Data Management personnel who are new to the system
    • attend meetings with clinical site to discuss labpas process issues and improvement
    • develop and maintain detailed working instructions

  • QC assistant

    April 2013 --- May 2013

  • Student Biochemistry & Biotechnology

    September 2006 --- September 2012

Knowledge

LinkedIn Assessment :
Biotechnologymolecular biologyPCRBiochemistryMicrobiologyLifesciencesMicrosoft OfficePharmaceutical IndustryCell CultureClinical Data Management (CDM)Early Phase Clinical ResearchSDTMCDISCICH-GCPResearchLabPaseSourceeClinical OSMicrosoft ExcelProject ManagementMedical DevicesGMPStrategic PlanningHPLCWestern BlottingEnzyme-linked immunosorbent assay (ELISA)Protein AssaysProtein PurificationSDS-PAGE

Education

  • Master of Science in Biochemie & Biotechnologie: Molecular and Cellular Gene Biotechnology from Universiteit Antwerpen in 2012
  • Bachelor in Biochemie & Biotechnologie from Universiteit Antwerpen in 2010

Area / Region

Linkeroever, Belgium

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Belgium

Other Candidates in Antwerp

Other similar Candidates in Antwerp

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like