Regional Implementation Manager - Regional Change Management
Since October 2016
Support the modernization of the clinical trial management system in the region (20+ countries). Ensure that the systems have the capability to support clinical trials management in terms of maintainability, compliance while taking advantage of the latest developments in the clinical trials space. Current focus on the CRO Onboarding : implementing outsourcing packages, training and external access management.
TMF Governance Committee Member
Since September 2014
TMF Governance Body -Development of operational guidance: identify the need for & approve process changes related to global TMF management. -Manage TMF portfolio and lead TMF improvement projects: bring forward process complexities, challenges and propose solutions -Guide /respond to/support inspection findings
Global Business Lead eTMF Tracking Solution
April 2016 --- October 2016
Solution/vendor assessment and preparation for implementation of a Global TMF Document Tracking Solution across BI worldwide : RFP, USR, system interfaces, business process global harmonization and mapping, eTMF integration, validation, vendor qualification, contract negotiations.
Regional Lead eISF Implementation
March 2015 --- June 2016
Preparation, implementation and follow up of the eISF roll out in the Region (20 countries): Optimization of documentation management and communication with the investigator site staff via a web based portal, electronic Investigator Site File implementation, electronic safety distribution implementation, eTMF Integration
Group Leader - Regional Clin Ops
March 2013 --- October 2015
Leading a group of 35 Clinical Trial Coordinators and eCTMF specialists as well as 4 unit leaders. Manage capacities, perform recruitment and ensure personal development and talent management. Coordinate, harmonize and implement all trial documentation SOPs / processes and tools in the region; Manage documentation within the Region (20+ countries)to optimize speed, quality and efficiency of trial documentation. Support trial audit and inspections as needed. As a group leader, member of the Regional ClinOps management team, contributing to the departments strategic discussions and decisions, Talent management and oversight of ClinOps activities within the region.
Regional Clinical Trial Manager
December 2011 --- March 2013
Managing and coordinating international clinical trials in the Region: (20+ countries) , from early stages trial preparation (finalization of protocol), through submission , trial conduct and close out (DBL etc). Experience in fully insourced and partially outsourced trial set up. Close collaboration with CROs in all countries, support management of trial medication, import and export procedures
Head of Central Lab
February 2011 --- November 2011
Setting up and thereafter heading the central lab services in a CMO - outsourced from Assign Group. Setting up following new services:lab kit design and production, frozen sample transport and storage. Writing and implementing SOPs for these new processes and services : Organizing and performing internal training in a team of 10 persons. User requirement and system validation preparation for the lab kits and lab sample managing system. Close collaboration with the QA and Packaging departments. Selection and contracting of preferred partners (logistics, equipment, transport)
Clinical Project Manager (CPM)
September 2008 --- November 2011
Managing and coordinating international clinical trials at a CRO: from early stages trial preparation (finalization of protocol), through submission , trial conduct and close out (DBL etc). Experience in fully and partially outsourced services. Organizing and hosting international investigator meetings. Close collaboration with the Sponsors and CRAs in all countries, support management of trial medication, import and export procedures.
Clinical Project Manager (CPM)
December 2009 --- April 2010
Managing and coordinating international clinical trials in a biotech company-(outsourced from Assign). from early stages trial preparation (finalization of protocol), through submission , trial conduct and close out (DBL etc). Experience in fully and partially outsourced services. Close collaboration with the CROs in all countries, support management of trial medication, import and export procedures.
Business Development Executive and Clinical Project Manager
August 2006 --- June 2008
Business development for a CMO offering Packaging & Logistics services dedicated to (Pre)Clinical Research. Account manager for several Sponsors : Pharmas, Biotech, Research centers,... Designing and managing drug packaging and distribution, drug & sample logistics, sample storage for international projects based on draft/final protocols, special services for Phase I,...
Office for Infrastructure and Logistics
October 2005 --- February 2006
Setting up of a quality control system in accordance with European norms
Clinical Project Assistant
January 2000 --- January 2005
Support in all activities of packaging & logistics services in Clinical Research. Design and optimization for sample logistics and sample storage. Specialized in ground transport for batched frozen specimen shipments,full specimen tracking and on-site data cleaning.
January 2004 --- August 2004
Setting up of a microbiological lab in accordance with the ISO17025 norm
AdaptabilityAnalytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCompetitivenessCoordinationCreative thinkingCritical thinkingCuriosityEfficiencyFlexibilityInterest in knowledgeOptimismOrganizationPerspectiveProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineSociabilityStrategic thinkingTrust
Skills and Expertise
Analytical skills Control data Develop clinical trial protocols Guide students Create SOPs Build and manage the Trial Master File (TMF) Interact with nurses Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdjust methodsAdjust processes and methodsAdminister logisticsAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdvise on strategyApprove consent documentsApprove drug supply Approve Label Master SheetApprove patient informationApprove monitoring reportsApprove queriesArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with site trainingAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyBuild trial master file (TMF)Calculate trial timelinesCapture data on source documentsClinical data collectionCoach and provide guidance to clinical staff.Collaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationComplete study proceduresConduct close-out visitsConduct maintenance visitsConduct site initiationConduct studiesConduct the trialConfirm protocol compliancecontrol different protocol versions and other essential documentsControl protocol versionsControl studiesCoordinate logisticsCoordinate projectsCoordinate with the ethics commiteecoordinating research projectsCoordinate regular advisory boardCreate SOPsCreate study documentsCreates a collaborative team environmentData verificationDesign clinical presentationDesign information leafletDesign tracking systemDesign trial master file (TMF)Determine availability of facilities and equipment at the siteDetermine needsDevelop strong internal relationships with stakeholdersDevelop study budgetDevelop study metricsDevelop study timelinesDevelop training materialsDevelopment of Pharmacy manualDirect co-workersDiscuss treatments with investigatorDocument employees training requirementsEnsure consistency between the protocol and CRFEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Establish contractsEstablish professional relationships with partnersEstimate subject complianceEthics committee applicationEthics committee submissionsExecute internal/external quality assurance assessmentsFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesGuide staffIdentify and provide training to trial team and associated staffIdentify investigatorsIdentify growth / improvement potentialHandle incidentsIdentify risksIdentify sitesImplement data collection systemImplement data reporting systemsImplement ProcessesIndentify clinicians to conduct clinical trialsInformed consent processInitiate clinical trials Interact with computer specialistsInteract with CROsInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansInteract with regulatory stakeholdersLead studiesLead teamsLiaise with doctorsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record dataMaintain strong relationshipsManage budgetsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage clinical suppliesManage complexityManage contractors Manage global quality standardsManage multiple projectsManage trial master file (TMF)Monitoring enrolmentMonitoring subject complianceNegotiationNetwork
Engineer in Chemistry and Bio-Industries from Université libre de Bruxelles in 2004
European Baccalaureat in Sciences: Biology ; Chemistry, Physics from European School of Brussels in 1999
Training and Certification
Social Intrapreneurship : Innovations for Health and Wellness in 2016 Training