BrightOwl Loader Loading

Summary

7 years of pharma experience - entrepeneur - motivated - independent - efficient - team player - accurate - organised - dynamic

Experiences

Current Experience

  • Clinical Trial Lead


    Since January 2017

Past Experience

  • Study Start-up Specialist

    August 2016 --- January 2017

  • Clinical Operations Manager

    February 2015 --- August 2016

  • Clinical Research Associate (CRA)

    June 2012 --- February 2015

  • Senior Associate Clinical Contracts & Budgets

    December 2010 --- June 2012

  • Clinical Trial Assistant (CTA)

    November 2009 --- November 2010

Personality

BrightOwl Assessment :
CuriosityAssertivenessStrivingEfficiencyOrganizationDiligencePerspectiveApproachabilityReaction to stressInterest in knowledge
Self Assessment :
IndependenceInterest in knowledgeSelf-confidenceAttention to detailOrganizationEfficiencyAssertiveness

Knowledge

BrightOwl Assessment :
Cardiovascular diseasesHematologyGastroenterologyClinical researchLegal Considerations: Contracts and IndemnityScientific methodologyEnglishscienceFrenchdutchPhase IIPhase IIIPhase IV
Self Assessment :
Cardiovascular diseasesGastroenterologyGeneral practiceHematologyPhysical medicine and rehabilitationClinical researchICH GCP guidelinesEthics submission and approval processClinical trial budgetingLegal Considerations: Contracts and IndemnityPhase IIPhase IIIPhase IV
LinkedIn Assessment :
Contract negotiationICH-GCPClinical researchClinical trialsoncologyEnglishFrenchProblem SolvingBudget NegotiationCardiologyBoneCTMSeClinicalClinical monitoringElectronic Data Capture (EDC) Pharmaceutical IndustryClinical DevelopmentGCP

Skills and Expertise

BrightOwl Assessment :
lifescienceCommunicate with investigatorConduct the trialCollaborate with project teamNegotiate budget Solve problems Monitor a clinical studyRegulatory documentationProtocol managementCoach staff Monitor a clinical studyManage study budgetContract approval
Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsArchive trial documentation and correspondence.Attend seminars, courses and meetings within and outside the companyBuild and manage the Trial Master File (TMF)Coach 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 documentsCoordinate approval of new study agreements and contracts.Determine availability of facilities and equipment at the sitedevelop the study budgetEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsEthics committee submissionswrite and maintain clinical evaluation reportsUpdate Clinical Trials Management System (CTMS) Work collaboratively with the other members of the clinical research team Train off site staff to trial specific and industry standards.put together a succesful ethics committee applicationPerform 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.manage study budget and maintain it within financial goalsInitiate clinical trials

Education

  • Master in Rehabilitation and physiotherapy (internal disorders) from Universiteit Gent in 2009
  • in Latijn-Wiskunde from Sint-Vincentiusinstituut Dendermonde in 2004

Work Preferences

  • Positions I am interested in:
    Medical Devices Medical Sales Representative Sales representative Product Specialist
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80-100% FTE
    BrightOwl employee :    80-100% FTE
  • International:
    Yes

Area / Region

Dendermonde

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Belgium

Other Candidates in Dendermonde

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like