BrightOwl Loader Loading

Experiences

Current Experience

  • Director Clinical Research

    Rotterdam, The Netherlands
    Since May 2012


Past Experience

  • Director Clinical Operations, Start-up Services, Europe, Asia-Pacific and Africa Mechelen

    September 2008 --- May 2012

Personality

BrightOwl Assessment :
Self-confidenceEfficiencyOrganizationKindnessAuthenticityCreative thinkingPerspective
Self Assessment :
Self-confidenceEfficiencyAdaptabilityCreative thinkingAssertivenessSociabilityOptimismIndependence

Knowledge

BrightOwl Assessment :
RheumatologyMedical oncology NeurologyHematologyDrug development processClinical trial designPhases of clinical development (phase I to IV)Understanding of regulatory guidelinesEthics submission and approval processPrinciples and ethics of clinical researchEndocrinology and metabolismProject ManagementMonitoring Study ProgressClinical trial budgetingWriting Study Procedures and SOPsClinical trial audits and inspectionsGood Clinical Practice (GCP)Knowledge of the drug development processDeveloping Clinical Trial ProtocolsAllergy and immunology
Self Assessment :
Allergy and immunologyCardiovascular diseasesEndocrinology and metabolismGastroenterologyGynecologic oncologyHematologyNeurologyMedical oncology RheumatologyDrug development processClinical trial designPhases of clinical development (phase I to IV)Developing Clinical Trial ProtocolsPrinciples and ethics of clinical researchICH GCP guidelinesEthics submission and approval processInformed Consent ProcessProject ManagementMonitoring Study ProgressClinical trial budgetingWriting Study Procedures and SOPsClinical trial audits and inspectionsGood Clinical Practice (GCP)Design and tracking systemsKnowledge of the drug development processUnderstanding of regulatory guidelines

Skills and Expertise

BrightOwl Assessment :
assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.implement quality control process throughout the conduct of the trialdevelop and manage comprehensive study timelines and metrics;develop the study budgetDevelop ICH/GCP compliant processesDesign a tracking systemCoach and provide guidance to clinical staff.Calculate timelines for conducting and completing the trialAttend seminars, courses and meetings within and outside the companyAttend at steering committee meetingsSupervise clinical monitorsAssemble regulatory applicationsApprove the supply of formulated drug to outside clinicians who wish to conduct human studiesPlan work to meet objectives and deadlines
Self Assessment :
assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Approve suitability of patient information and consent documentsAssemble regulatory applicationsAssign, coordinate and supervise day-to-day activities of clinical study monitorsAttend at steering committee meetingsAttend seminars, courses and meetings within and outside the companyCalculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Design a tracking systemDevelop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials develop the study budgetdevelop and manage comprehensive study timelines and metrics;implement quality control process throughout the conduct of the trialPlan work to meet objectives and deadlines

Education

  • Graduated Nursing in from Katholieke Hogeschool Leuven in 1989

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee
  • International:
    Yes

Area / Region

Hoegaarden

Others

Driving License
  • No

Similar Candidates

Other Candidates in Belgium

Other Candidates in Hoegaarden

Other similar Candidates in Hoegaarden

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like