Clinical Research Associate (CRA)Mechelen, Belgium
Since June 2015
Clinical Data Manager (DM) Mechelen, BelgiumJune 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 assistantApril 2013 --- May 2013
Student Biochemistry & BiotechnologySeptember 2006 --- September 2012
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