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• Scientific background with 15 years of experience in Clinical Research
• Very efficient resulting in quick responses and results
• Proactive thinker, likes to foresee possible issues and analyze problems
• Always looking for long term solutions and efficiency gains
• Sets quality as top a priority
• Very good knowledge of procedures, laws and regulations
• Good organizational and project management skills, sets clear expectations
• Problem solver, likes to think out-of-the-box
• Likes to interact and collaborate with others at all levels, to look for opportunities and
negotiate to obtain win-win results
• Team minded and eager to learn
• Trilingual (Dutch, French, English) with fluent writing skills
• Line management experience with the skills necessary to direct, train, challenge and
motivate staff to its fullest potential with a proactive approach and to resolve conflicts


Current Experience

  • Clinical Project Lead Wavre, Belgium
    Since February 2017
    First in human medical devices study set-up in ophthalmology. Protocol writing, CRF creation, site selection, vendor managament, etc...

Past Experience

  • Senior Clinical Project Manager (CPM) Leuven
    November 2014 --- November 2016

    Trial management HQ level including developing and managing clinical project budgets, RFP, CRO and vendor management, IMP forecasting, etc...

    Trial Management including preparation of protocol and ICF, status reports, RFPs, CRO and vendor selection, collaboration and management of CROs and other vendors, UAT, approval of documents such as monitoring and study plans, CRF, IVRS, study guidelines, budget and contract negotioations, etc

    Ophthalmology projects phase II and IV: Study start-up and conduct.

  • Clinical Research Manager Brussels
    March 2012 --- October 2014

    • CRA and CTC management with 10-11 direct reports
    • Vendor relationship management
    • Training & quality assurance in-house and at site
    • Problem solving, recruitment and retention discussions with sites
    • Quality control visits and co-visits with CRAs
    • Informed consent subject matter expert
    • SOP writing & training
    • Support to Medical Affairs Managers for set-up of LCEs
    • Project Manager for a large cardiovascular trial

  • Clinical Project Manager (CPM) Brussels
    July 2010 --- February 2012

    • Site validations to close-out
    • In-house studies in cardiovascular, vaccines, diabetes and neurology
    • Outsourced studies point of contact for vendors

  • Clinical Research Operations Manager Diegem
    June 2008 --- June 2010
    • CRA and CPA management with 8 direct reports • Quality assurance & training • Responsible for SOP review, writing & training • Operations management post-marketing projects (Phase IV studies, registries, CUP, MNP, PSP, IST) • Trial manager support (protocol writing, CRF development, feasibility…) • Point of contact for medical affairs managers, market access manager and external vendors • Training and support of investigators for IST (GCP, laws & regulations, study conduct) • Study budgets review and operational budget support

  • Trial Manager Diegem
    April 2008 --- May 2008
    Cardiovascular Phase IV study

  • Clinical Research Associate (CRA) Brussels
    July 2002 --- April 2008
    • Experience in fase II, III and IV trials in Pneumology, Cardiology, CNS and Diabetes. • SOP training and coaching of new CRAs • Quality assurance internal templates such as contracts, informed consents and backtranslations. • Active participation in an international working group to develop a Site Management System (>2 years).


Self Assessment :
EfficiencyPerspectiveAdaptabilityCreative thinkingInterest in knowledgeDependabilitySociabilityIndependenceResiliencyOrganizationTrustCritical thinkingAttention to detailCoordinationProactivity


BrightOwl Assessment :
Vaccines DiabetesNeurologyCardiology
Self Assessment :
Cardiovascular diseasesDeveloping Clinical Trial ProtocolsMonitoring Study ProgressICH GCP guidelinesEthics submission and approval processProject ManagementInformed Consent ProcessInformed Consent DocumentsPatient Follow UpIt skillsCTMSPatient Screening and RecruitmentClinical trial audits and inspectionsWriting Study Procedures and SOPsElectronic Data Capture (EDC) Clinical trialsClinical researchPharmaceutical IndustryICH-GCPGood Clinical Practice (GCP)NeurologyGynecologic oncologyEndocrinology and metabolismVaccinesGastroenterologyAllergy and immunologyHematologyInfectious diseasesPulmonary diseasesPhases of clinical development (phase I to IV)MultilingualdutchEnglishTeamworkFrenchRheumatologyDesigning case report formsCROOphthalmologystudy managementIVRSCRO managementVendor ManagementClinical trial managementstudy start-upBudget ManagementBudget NegotiationClinical trial budgetingContract negotiationCRF developmentIWRS developmentCRO selectionvendor selection

Skills and Expertise

BrightOwl Assessment :
Coach clinical staffInitiate clinical trials Design case record formsCTMS Build and manage the Trial Master File (TMF)
Self Assessment :
Update Clinical Trials Management System (CTMS) Maintain and manage internal clinical trial files and documentsInterface with CROs and other contractors with guidance in order to implement clinical trial programs efficientlyInteract with physiciansInteract with computer specialistsInitiate clinical trials Indentify, meet, interview and persuade investigators to conduct clinical trialsimplement quality control process throughout the conduct of the trialIdentify site issues and initiates correction plans based on monitoring reports.Identify and provide training to trial team and associated staffEvaluate, review and assess protocols and amendments for feasibility manage study budget and maintain it within financial goalsOversee outsourced data management activitiesperform Data verificationTrain off site staff to trial specific and industry standards.Review and approve monitoring reports, track ongoing issues and query resolutionRead medical literature to maintain current awareness and knowledgeput together a succesful ethics committee applicationPrepare required regulatory documentsPrepare regulatory documentation packets prepare study-related documentation; Prepare referral lettersPlan work to meet objectives and deadlinesPerform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.Ensure consistency between the protocol and CRFensure audit-ready condition of clinical trial documentation including central clinical files;Capture pertinent data onto source documents (i.e., vital signs, adverse events, concomitant medications, etc.).Calculate timelines for conducting and completing the trialattend Investigator meetings requiring travel and report pertinent information back to research team members.Build and manage the Trial Master File (TMF)Attend seminars, courses and meetings within and outside the companyAssign, coordinate and supervise day-to-day activities of clinical study monitorsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.assess operational feasibility and recommend study execution planApprove suitability of patient information and consent documentsAssess subject safety during trialCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.control different protocol versions and other essential documentsEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsDirect co-workers to achieve resultDesign patient recruitment advertisements Develop and maintain tracking systemsDevelop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Determine availability of facilities and equipment at the siteDesign case record formsCreate clinical project documents according to the protocolCoordinate with the ethics committeeCoordinate approval of new study agreements and contracts.Act as the main line of communication between the sponsor and the investigatorCRO and vendor selection and managementcontract and budget negotiationsreview and approval all clinical study documentsUAT Create SOPs Design case record forms Develop protocolsCalculate trial timelinesCollaborate with project teamCollaborate with medical teamDevelop study budgetDevelop study timelinesInteract with CROsManage study budgetManage study supplyManage vendor budgetsNegotiate budget Review study protocolsReview vendor reportsSelect contractors Set up a clinical study


  • Teaching degree in Biology from KU Leuven in 1999
  • Master of Science (MSc) in Biology from KU Leuven in 1998


BrightOwl Assessment:
Self Assessment:
Professional Proficiency
Professional Proficiency
Elementary Proficiency
Elementary Proficiency
Elementary Proficiency
Elementary Proficiency

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Clinical Project Leader Clinical Project Manager (CPM) Clinical Research Manager Clinical Trial Manager Clinical Research Associate (CRA) Associate Director Clinical Operations Project Leader Project Manager Senior Project Manager (PM)
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
  • International:

Area / Region



Driving License
  • Yes