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Past Experience

  • Clinical Project Manager (CPM) Homebased
    August 2014 --- April 2016

    • Managing projects of full scope regional and global medical device trials (domain of orthopedics and cardiovascular therapies)
    • Responsible for project team leadership
    • Managing and leading cross-functional project teams
    • Managing day-to-day operational aspects of assigned projects
    • Primary contact point for sponsor and vendors
    • Responsible for building and maintaining positive client relationships
    • Ability to negotiate with clients to assure operational processes are maintained and projects are done within scope
    • Reviewing and identifying project study trends and proactively responding to client and respective team members
    • Identifying and defining document training requirements and assuring project level compliance with study specific training requirements
    • Responsible for change management on all assigned projects
    • Responsible for assuring projects assigned are run according to SOPs and WPs as refined in the contract
    • Responsible for assuring project timelines are met as per contract
    • Responsible for identifying processes and study plans which need updating
    • Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
    • Managing project budgets
    • Assisting in preparing and presenting during proposal defense presentations to prospective clients
    • Supporting contracts and proposals team with final project contract execution and change in scope documentation

  • Sabbatical year
    August 2013 --- August 2014

  • Clinical Research Specialist Mechelen, Belgium
    April 2011 --- April 2013

    • International project management of a medical device trial (domain of cochlear implants) with centers in 4 European countries (Belgium, Germany, Spain and Poland)
    • Coordinating the writing and set-up of study documents in cooperation with field specialists, coordinating the development of the eCRF in cooperation with an external party
    • Coordinating ethics committee and competent authority submissions in cooperation with local CRAs, managing site contracts & site initiations, providing eCRF training, organizing investigator meetings, supply management, writing study newsletters, reviewing SOPs, helping in preparation and set-up of a post-marketing trial,....

  • Clinical Trial Manager Zaventem, Belgium
    June 2009 --- April 2011

    • Coordinating all processes to run a medical device trial (indication: lumbar spinal stenosis, international: Belgium, UK)
    • Ensuring timely and high quality data within the budget, managing the study team consisting of CRA's, a CTA, data management provider, statistician, CRF provider and imaging readers/lab
    • Coordinating processes like ethics committee and regulatory submissions and correspondence, keeping recruitment on track, keeping data collection and cleaning on track, working closely together with the medical team for development of the study protocol/amendment and follow up of patient safety,…

  • Principal Clinical Research Associate Zaventem, Belgium
    June 2007 --- June 2009

    • Monitoring medical device trials (domain of minimally invasive spine therapies; international: Belgium, France, The Netherlands, Germany)
    • Performing co-monitoring visits
    • Active participation in planning, design, development, implementation and completion of medical device studies and other research activities,....

  • Clinical Research Associate (CRA) Zaventem, Belgium
    November 2005 --- June 2007

  • Clinical Research Associate (CRA) Uccle, Belgium
    April 2005 --- November 2005

    • Monitoring clinical trials (phase III; domain of oncology; study centers in Belgium)
    • Maintain close contact with the study centers in order to follow the recruitment, motivate and support them if necessary, collect CRFs and resolve queries on a regular basis, handle all SAEs/SAE FUs according to local safety instructions and guidelines, …..

  • Clinical Research Associate (CRA) Braine-l'Alleud, Belgium
    June 2004 --- March 2005

    • Monitoring clinical trials (phase I, II and III; domain of gastroenterology, allergy and CNS; international: France, UK, Greece, Spain)
    • Assuring the quality of the clinical data, selection of sites, site evaluation visits, initiation visits, conducting and reporting monitoring visits, conducting source data verification and in house review of clinical data
    • Ensuring timely resolution of data queries to guarantee reliable clinical data, assisting in conducting and reporting study termination and related activities,…

  • r&d Assistant Destelbergen, Belgium
    December 2001 --- June 2004

    • Help in the set-up of pre-clinical and clinical study protocols
    • Statistical processing of (pre)-clinical study results
    • Writing scientific reports and abstracts (with study results), literature research
    • Laboratory work
    • Monitoring clinical studies (phase I, II and III; domain of soft tissue disorders and osteoporosis; international: UK) and follow up of contacts with research institutes.


Self Assessment :
Attention to detailCoordinationCreative thinkingEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOrganizationProblem solvingResponsibilityResult Oriented


Self Assessment :
R&DAdverse Events (AE)Biomedical SciencesCancer ResearchClinical monitoringClinical operationsClinical researchClinical trial budgetingClinical trial managementClinical Trial Management System (CTMS)CROCRF designData entryData cleaningeCRFInformed Consent ProcessInformed Consent DocumentsInternational Project ManagementMedical DevicesISO 14155ICH-GCP


  • Master in Biomedical Sciences from University of Brussels in 2001


BrightOwl Assessment:
Self Assessment:
Professional Proficiency
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM)
  • Work From Home:
    Yes, 3 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:

Area / Region



Driving License
  • Yes