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Summary

your Partner in • Clinical research Training • rescue monitoring • gcp Compliance checks • consultancy • team management (time, Communication, mbti®,…) Trainer for junior CRA, advanced CRA, cta, investigational staff, investigators, eu directives & guidelines, Auditing & inspections, Time Management and train the Trainer programs. specialized in performing gap analyses and designing Training plans for clinical and medical departments. writer of a handbook for monitors; "best practice for Clinical monitoring" vice chair of the board of efgcp and active in the efgcp working party on Education. qualified mbti step i assessor specialties: ich-gcp eu Clinical Trial directive eu gcp directive Time Management Clinical operations Training Training management mbti

Experiences

Current Experience

  • Vice Chairman of the Board


    Since May 2014
    the european forum for Good Clinical Practice (efgcp) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of Biomedical Research. its purpose is to promote Good Clinical Practice and encourage the practice of common, high-quality standards in all stages of Biomedical Research throughout europe. The European Forum for Good Clinical Practice (EFGCP) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe.

  • Managing Director


    Since April 2011
    specialised worldwide Consultant in: Training o ich-gcp o ich-gcp refresher o ISO 14155 o monitoring for junior CRA’s o monitoring for experienced CRA’s o Clinical research Training for trial assistants o clinical reserach Training for site staff o Clinical research Training for investigators o european legislation for Pharmaceutical trials o european legislation for Medical Device trials rescue monitoring • aid current trials going wrong • help in site alignment and ComplianceCRA Coaching • co-monitoring • extra need of a CRA gcp Compliance • review of current activities • see if they are in line with ich-gcp or ISO 14155 • mock audit consultancy • give advice on ich-gcp, ISO 14155 or eu law • give advice on team management • give advice on Training and Training plans • implement Training procedures team management • Training and Coaching on Time Management • train the Trainer • general Communication Skills • mbti o Change Management o team communication o conflict management o … • Team Building activities Specialised worldwide consultant in: Training o ICH-GCP o ICH-GCP refresher o ISO 14155 o Monitoring for Junior CRA’s o Monitoring for experienced CRA’s o Clinical Research Training for Trial Assistants o Clinical Reserach Training for Site Staff o Clinical Research Training for Investigators o European Legislation for Pharmaceutical Trials o European Legislation for Medical Device Trials Rescue Monitoring • Aid current trials going wrong • Help in site alignment and compliance • CRA coaching • Co-monitoring • Extra need of a CRA GCP Compliance • Review of current activities • See if they are in line with ICH-GCP or ISO 14155 • Mock audit Consultancy • Give advice on ICH-GCP, ISO 14155 or EU law • Give advice on team management • Give advice on training and training plans • Implement training procedures Team Management • Training and coaching on Time Management • Train the trainer • General Communication skills • MBTI o Change Management o Team communication o Conflict Management o … • Team building activities

Past Experience

  • Managing Director

    March 2013 --- December 2014
    the european centre for Clinical research Training is a division of the harrison Clinical research group and our primary focus is to serve as a Training centre for professionals in the Pharmaceutical, biotechnological and academic Clinical research environment. the courses we offer are tailored to every level of experience and are divided into modules ranging from an introduction course to Clinical research and monitoring, to current regulatory requirements of Clinical trials and specific Medical Research areas such as the development of Vaccines or understanding the ecg trace in Cardiology trials. in addition, we are also able to provide tailored courses, specifically designed to your Training needs and given on-site at your company or institution.

  • Manager Training Department

    March 2013 --- December 2014
    heading the global Training department of a full-service contract Research organization, operating in 16 countries.

  • Member of Board

    January 2012 --- May 2014
    the european forum for Good Clinical Practice (efgcp) is a non-profit organisation established by and for individuals with a professional involvement in the conduct of Biomedical Research. its purpose is to promote Good Clinical Practice and encourage the practice of common, high-quality standards in all stages of Biomedical Research throughout europe.

  • Training Manager

    October 2010 --- March 2013
    operational manager of all courses, communications and negotiations with Consultant trainers, Line Management of the entire eccrt team, general qa of Training materials and follow up of course evaluations.

  • Trainer

    March 2009 --- September 2010
    Training preparation, hosting and delivery of both in-house as tailored Clinical research courses.

  • Senior Clinical Research Associate

    January 2007 --- January 2009

  • Clinical Research Associate (CRA)

    January 2004 --- January 2007

  • Clinical Research Associate (CRA)

    January 2001 --- January 2004
    in this CRO environment i was outsourced to medtronic Medical Devices (1+ year), sanofi - synthelabo (1+ year) and amgen.

  • Clinical Research Associate (CRA)

    January 2000 --- January 2001

Personality

Self Assessment :
Attention to detailCreative thinkingCollaborationEfficiencyFlexibilityOrganizationProblem solvingSelf-confidenceReaction to stress

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryTherapeutic AreasPharmaceuticsCTMSTrain the TrainerICH-GCPTime ManagementClinical trialsClinical researchClinical monitoringRegulatory RequirementsClinical trial managementClinical DevelopmentRegulatory affairsRegulatory submissionsMedical DevicesEuropean LawGXPPatient recruitmentGCPPresentation DevelopmentPublic SpeakingTeam ManagementTeam LeadershipFDACROMBTISOP

Skills and Expertise

Self Assessment :
Guide students Monitor a clinical studyAdjust processes and methods Control dataAssign activitiesAttend seminarsCoachConduct the trialcoordinating research projectsDevelop ICH/GCP compliant processesGuide staffmanaging a small teamNetworkOral presentationPresent clinical resultsPresent data at congressProvide trainingQuality control processSolve problemsTrain off site staffTrain on site staff

Education

  • Master in Physical Education from Vrije Universiteit Brussel in 2000
  • in from KA Zaventem in 1995

Training and Certification

  • MBTI Step I Assessor in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Professional Proficiency
English
Full Proficiency

Work Preferences

  • Work From Home:
    Yes, 1 to 5 days per week
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Zaventem, België

Others

Driving License
  • Yes

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