Clinical Research Associate (CRA) Mechelen, Belgium
Since June 2015
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 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
April 2013 --- May 2013
Student Biochemistry & Biotechnology
September 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