Senior Clinical Trial Manager
Since April 2014
Responsible for providing clinical study management by participating in the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH-GCP Guidelines and SOPs.
March 2013 --- March 2014
Synteract and HCR have joined forces.
December 2010 --- February 2013
Planning, budgeting, execution and implementation of clinical trials and follow-up on agreed milestones and budgets of these trials on behalf of clients to the standard of ICH/GCP, applicable local regulations and applicable QSPs.
Sr. Clinical Research Associate
January 2008 --- December 2011
Central study coordination and site management for national and international phase I-IV studies, inclusive medical device studies. Coaching of Jr. CRA's.
Clinical Research Associate (CRA)
October 2005 --- January 2008
Organization, coordination, administrative management, monitoring and site management of national and international clinical trials (phase I-IV) according to ICH-GCP and FDA CRF 21, if applicable.
Self-confidenceApproachabilityInterest in knowledgeTrustDependabilityEfficiencyAnalytical thinkingOrganization
Analytical thinkingApproachabilityCollaborationCoordinationCuriosityOrganizationProactivityResult OrientedService oriented
Clinical trialsPhases of clinical development (phase I to IV)CoachingBiomedical SciencesBudget ManagementClinical monitoringProject ManagementProject CoordinationTeamworkProblem SolvingLife SciencesEthics submission and approval processCommunication Skills
Skills and Expertise
Analytical skills Create SOPsAdjust processes and methodsAdvise on strategyCoachCollaborate with project teamCommunicationComplete case report form (CRF)Creates a collaborative team environmentCreate SOPsDevelop clinical strategyIdentify growth / improvement potentialInteract with ethics committeeLiaise with professionals in other divisions of the company as requiredlifesciencePlan work to meet objectives and deadlinesproject managementProvide trainingReview reportsWork collaboratively with the other members of the clinical research team Work cross-functionally
Monitor a clinical studyAdjust processes and methodsApprove monitoring reportsApprove patient informationAssess site feasibilityAssist study siteAttend investigator meetingCalculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Collaborate with project teamCommunicate with investigatorCommunicate with sponsorCommunicationConduct close-out visitsConduct site initiationCreate clinical documentsCreate SOPsCreate study documentsData verificationDesign clinical presentationDesign study documentsDevelop clinical strategyDevelop ICH/GCP compliant processesDirect co-workersDirect co-workers to achieve resultEnsure good clinical practice (GCP)Ethics committee applicationFollow-up of internal auditsGastrointestinal diseasesIdentify risksLogging enrolmentManage budgetsManage clinical suppliesManage Clinical Trial Management System (CTMS) Manage study supplyManage trial master file (TMF)Monitor Key Performance Indicators (KPI's)Observe trends in dataOversee data collectionPatient recruitmentPlan work to meet objectives and deadlinesPlanning clinical studiesPre-study procedures project managementProvide trainingRespond to audit findingsReview reportsSet up a clinical studySite managementTrain StaffTranslate strategy into operational plansWork collaboratively with the other members of the clinical research team Work cross-functionally
Master's degree in Biomedical Sciences, General from Universiteit Gent in 2005