Aiming for excellence in your projects!
International Project Manager Clinical Research
Since May 2014
Clinical Monitor (clinical project manager)
April 2010 --- May 2014
Managing clinical research projects on a local and regional (Benelux) level in the field of oncology, respiratory and CNS. Involved in the local and regional change and implementation of company's SOP's. Involved in the development and implementation of quality improvement projects in clinical research. Involved in the development of clinical project plan for local clinical project managers.
Clinical Research associate via Valesta
June 2008 --- March 2010
Monitoring of clinical trials on a local level in the field of oncology, respiratory and CNS.
Clinical Manager Europe via Valesta
January 2007 --- January 2008
Management of sales and marketing activities of medical devices at a European level. Implementation of first in-human trial of medical devices in Germany.
European Trainer Interventional Systems
January 2007 --- June 2007
Training of European Sales Team in the cardio-vascular medical device portfolio of Terumo Europe.
Nurse Specialist Adult Congenital Cardiology
December 2003 --- December 2006
Intensive care nurse
July 2000 --- December 2006
ApproachabilityAttention to detailCoordinationCreative thinkingDependabilityEfficiencyInnovative thinkingOrganizationProblem solving
Skills and Expertise
Assure medical quality Build and manage the Trial Master File (TMF) Control data Create SOPs Develop clinical trial protocols Guide students Interact with nurses Interact with physicians Monitor a clinical study Report data Search literature on clinical trials Use content management systems Write papersAdjust processes and methodsApprove consent documentsApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesArchive documentationArchive study documentsAssess site feasibilityCoachCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamConduct monitor visitsConduct literature searchesConduct site initiationConduct the trialConduct university research Confirm protocol complianceContract approvalCoordinate regular advisory boardCoordinate with the ethics commiteecoordinating research projectsCreate clinical documentsCreate SOPsCreate study documentsData verificationDesign information leafletDevelop study budgetDevelop study metricsDevelop study timelinesDirect co-workersEnsure good clinical practice (GCP)Ethics committee applicationEthics committee submissionsEvaluate protocolsFinancial administrationFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGeneral office managementHandle callsInteract with CROsInitiation visitManage study budgetManage study supplyManage subject consent formManage trial master file (TMF)Negotiate budget Negotiate payment schedulesNegotiate protocol details Patient recruitmentPreparing referral lettersPresent clinical resultsPresent data at congressProvide medical insightsProvide trainingRead medical literatureRegulatory documentationRegulatory submissionsReview vendor reportsSelect contractors Set up a clinical studySite managementStudy execution planSupervise clinical monitors
Post-graduate degree in from Katholieke Universiteit Leuven in 2008
Master in from Katholieke Universiteit Leuven in 2006
Bachelor in from Katholieke Hogeschool Leuven in 2001
Bachelor's degree - RN in from Katholieke Hogeschool Leuven in 2000