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Summary

Key activities include developing approval tactics, organising trials, developing and/or adapting SOP’s, GCP’s and Protocols etc, over-viewing and monitoring trials, negotiating with vendors, managing risk, safety and adverse events and preparing documentation and reports Major focus: interventional cardiology Specialties: Training Clinical research Medical devices

Experiences

Current Experience

  • Sr. Director Clinical Affairs EMEA Belgium
    Since May 2017
    Key activities include developing approval tactics, organising trials, developing and/or adapting SOP’s, GCP’s and Protocols etc, over-viewing and monitoring trials, negotiating with vendors, managing risk, safety and adverse events and preparing documentation and reports with a focus on Interventional Cardiology.

Past Experience

  • Director Clinical Affairs EMEA
    June 2014 --- April 2017

    Key activities include developing approval tactics, organising trials, developing and/or adapting SOP’s, GCP’s and Protocols etc, over-viewing and monitoring trials, negotiating with vendors, managing risk, safety and adverse events and preparing documentation and reports with a focus on Interventional Cardiology.

  • Project Manager
    June 2011 --- May 2014
    Project Manager EEMEA THV Clinical Project Manager with substantial experience in implementing and coordinating assigned clinical research projects within EMEAC related to Cardiology according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, National regulatory bodies. Create and/or review case report forms. Site selection, initiation, training, monitoring and auditing. Prepare and submit progress reports of monitored sites.

  • Sr. Clinical Research Specialist
    January 2011 --- February 2013
    Sr. Clinical research specialist Transvascular Heartvalve Therapies in field of Aortic and Pulmonic heart valve

  • Clinical Research Specialist THV
    September 2007 --- January 2011
    Clinical research specialist Transvascular Heartvalve Therapies extended role in combination with clinical product specialist in Field of Aortic and Pulmonic valve Clinical research specialist with substantial experience in implementing and coordinating assigned clinical research projects within EMEAC related to specific products according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, National regulatory bodyies. Create and/or review case report forms. Site selection, inititation, training, monitoring and auditing. Prepare and submit progress reports of monitored sites. Maintains close contact with clinical study site coordinators and physicians who are clinical investigators

  • Clinical Research Specialist Critical Care
    June 2006 --- September 2007
    Clinical research specialist Critical Clinical research specialist with substantial experience in implementing and coordinating assigned clinical research projects within EMEAC related to specific products according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, National regulatory bodyies. Create and/or review case report forms. Site selection, inititation, training, monitoring and auditing. Prepare and submit progress reports of monitored sites. Maintains close contact with clinical study site coordinators and physicians who are clinical investigators

  • President
    January 2000 --- January 2007
    CICEN is small society specialised in high quality ICU nursing training. They have a yearly congress focused on one hot topic. My role was but not limited to: Setting up a scientific committee Inviting speakers Contact between society and congress centre/catering Editor of the congress book Creating the congress poster and flyers

  • Professional Services Specialist Cardiology
    May 2005 --- June 2006
    Responsable training and education worldwide cathlab application

  • International Clinical Application Specialist
    May 2004 --- May 2005
    Responsable training and education worldwide Pulsion products. Trained dealers and visited KOL meanly on PiCCO. The intensive build up relatonship resulted in a raise in device sales

  • Critical Care RN
    February 1988 --- April 2004
    Medical Intensive Care with various training responsibilities: - Hemodynamic measurements - Ventilation strategies - Renal replacement therapies Part of the working group to renovate the unit

  • Critical Care RN
    February 1988 --- February 1989
    ICU and High Care Burn unit during military Service

  • RN
    July 1987 --- February 1988
    Cardio-Thoracic and vascular surgery ward.

Personality

Self Assessment :
Analytical thinkingAssertivenessCompetitivenessCritical thinkingIndependenceStrategic thinkingProblem solvingEmotional reactivity

Knowledge

Self Assessment :
Medical devicesCardiologyCardiovascular diseasesClinical Data Management (CDM)Clinical monitoringClinical researchClinical Study DesignContract negotiationCTMSElectronic Data Capture (EDC) Emergency medicineFlow CytometryGCPICH GCP guidelinesInternal medicineMedical Devicespeople managementProtocolTeam Leadership
LinkedIn Assessment :
Medical DevicesClinical researchCardiologyCritical CareNursingClinical trialsLifesciencesMedicineHealthcareICUHospitalsProtocolNeurologyInterventional CardiologyFDALife Sciences

Skills and Expertise

Self Assessment :
Create standard operating procedure (SOP)Select contractors Select investigatorsNegotiationManage study budgetManage contractors Direct co-workersDevelop study budgetDevelop clinical strategyDesign protocolDesign post-marketing surveillance studyDesign Clinical Trial Management System (CTMS) Design clinical trialDesign case record form (CRF)Solve problemsGuide staffLiaise with doctorsManage projects resources

Education

  • in Post Graduate ECG from Universiteit Antwerpen in 2004
  • in Digitale kunst from Stedelijke Academie voor Beeldende Kunsten in 2004
  • Bachelor after bachelor in Nursing Management from Hogeschool Antwerpen in 1996
  • Bachelor after bachelor in Intensive Care Nursing from Arteveldehogeschool in 1993
  • bachelor in Nursing from Hogeschool Antwerpen in 1987

Training and Certification

  • Project Management, PMI in 2012 Training
  • Clinical Project Managment, WMDO in 2010 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Dutch
    Native
    English
    Full Proficiency
    French
    Elementary Proficiency
    German
    Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Publications

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

Area / Region

Willebroek, België

Others

Driving License
  • Yes