Since July 2014
Jr. Project Manager
June 2013 --- June 2014
Clinical Research Associate (CRA)
March 2012 --- June 2013
Clinical Design Manager
March 2009 --- December 2011
Creation of EDC pages directly from protocol or schedule of events. Provide expert opinion on the content of CRFs/eCRFs and ensure the final CRF/eCRF is fit for purpose as appropriate for the capture of all required data. Generation of training materials (user manuals and online training tools) for study specific eCRFs. Text editing and writing for marketing purposes.
CRF designer/Data Reviewer
February 2005 --- February 2009
CRF and Medical review of clinical phase I and II trials. Creating of DCFs (Data Correction Forms). Coding of drugs and Adverse Events. Writing of Data Management Plan, Data Validation Plan. SAE reconciliation. Quality Control of the CDISC conversion. Quality Control of other clinical trials. Validation and design of edit checks and data listings. CRF design.
interim science teacher
September 2004 --- November 2004
short term interim assignment as science teacher: Mathematics, Chemistry and Physics for 2nd and 3rd degree students of KSO, TSO and BSO in SISA Antwerp.
Analytical thinkingApproachabilityAttention to detailCreative thinkingInterest in knowledgeProblem solving
Skills and Expertise
Analytical skills Analyze data Design case record forms Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trials Technology research Use content management systemsApprove queriesArchive study documentsArchive trial documentation and correspondence.Assist with site trainingAttend seminars, courses and meetings within and outside the companyClinical data collectionCollaborate with project teamCommunicate effectively on different company levelsCommunicate with sponsorCommunicate with investigatorCommunicationCreate study documentsData validationDesign case record form (CRF)Design clinical presentationDesign data collection systemsDesign data reporting systemsDesign marketing advertismentsDesign study documentsDevelop training materialsDirect co-workersFollow up projectslifescienceMaintain strong relationshipsManage budgetsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage data collection systemManage data reporting systemsManage multiple projectsOrganise meetingsOral presentationProvide technical supportProvide trainingRead medical literature to maintain current awareness and knowledgeStudy-related documentsTrain off site staffTrain on site staffUpdate Clinical Trials Management System (CTMS) Use content management systemsValidate dataWork with coordination and data management teamsWrite documentsWritten presentation
in Sharepoint from Cevora in 2012
in Adobe Illustrator from Executive computer training in 2011
master in Biology from Universiteit Antwerpen in 2003
Master of Science (MSc) in Specialized additional study Communication Sciences from Universiteit Antwerpen in 2003
in from Cevora's Indesign course in 0