the new challenges in Clinical research that i'm looking for is a strategic management role. i recently got accepted at the neoma business school, a triple-crown accredited executive mba which fully meets the international academic standards. the school conducts in-depth, business-relevant research and the professors are leading researchers with prior experience in some of the world's most highly reputed schools and universities. through this executive mba program i would like to strengthen my (project) management skills. 8 years of experience in the Pharmaceutical Industry; currently working as a clinical study manager, i started my Career in the Pharmaceutical Industry as a Medical Representative in 2007. i worked for the servier Pharmaceuticals company and was responsible for the commercial development of several drugs in Osteoporosis and Cardiology. in this role i organized medical events and provided medical trainings to Healthcare professionals. extensive international experience in Clinical research and ich-gcp certified; i moved to paris, france in the summer of 2009 and started a course in Clinical research at the leonard de vinci institute. i was hired at quintiles as a CRA and was promoted very quickly to senior CRA. i have monitored sites in france and the netherlands and remotely in belgium, switzerland and the united kingdom. i have extensive experience in Phase 3 and 4 studies in Cardiology, Neurology, Endocrinology and oncology. i am ich-gcp (good clinical practices) accredited. Project Management; the past 2,5 years i have been involved in Project Management.
Clinical Study ManagerEnter Location
Since April 2015
*review of monitoring visit reports on several studies, quality check of trail master file, review of inr trackers, provide eCRF trainings to monitors and medical reviewers both at CRO and sponsor level and several other coordinating tasks. *collection of essential documents, performing site initiation visits and Clinical lead tasks on a phase iiib, multinational, multicenter, open label, randomized withdrawal Pediatrics trial on hyponatremia.
*Review of monitoring Visit Reports on several studies, Quality Check of Trail Master File, Review of INR trackers, Provide eCRF Trainings to monitors and medical reviewers both at CRO and Sponsor Level and several other coordinating tasks. *Collection of essential documents, performing Site Initiation Visits and Clinical Lead tasks on a Phase IIIb, multinational, multicenter, open label, randomized withdrawal Pediatrics trial on Hyponatremia.
Senior Clinical Research Associate (CRA)January 2010 --- March 2015
*site initiation *site monitoring *site close-out *collect, track and review study site critical documents *coordinate site recruitment and enrolment efforts *evaluate and assure quality of data collected *monitor site and subject progress *assist the Clinical team in the filing and archiving of Clinical Documentation *review of Interim monitoring and close-out visit reports *management of central filing *quality check of performed monthly monitoring calls *acting as back up of the Project Manager
Medical RespresentativeJanuary 2007 --- July 2009
• commercial development of several drugs in Osteoporosis, Hypertension and angina pectoris • schedule management • Editing daily and monthly reports • project coordination • organisation of medical events • Editing commercial action plans • selection, initiation and follow up of post Marketing studies • provide medical Training to doctors
CommunicativeCollaborationAuthenticityAnalytical thinkingAdaptabilityCreative thinkingCritical thinkingCoordinationCharmCuriosityEfficiencyFlexibilityIndependenceProactivityResult OrientedSelf-disciplineService orientedSociabilityStrategic thinkingTrustResponsibility
Master of Business Administration (MBA) in Business Administration and Management, General from NEOMA Business School in 2017
Post-Graduate in Clinical Research from Leonard de Vinci in 2009
Bachelor in Economic Sciences from University of Amsterdam in 2004