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Summary

nadia at a glance:

  • experienced scra (17 y ) : feasibilities, ha and ec submissions, initiation, monitoring, close outs,
  • phases i, ii, iii, iv, pass
  • oncology (lung, gastric, colorectal, hepatology, ovarian, breast, prostate..), Gastroenterology, rare diseases, Cardiology, Rheumatology , Neurology, phytotherapy, Medical Devices...
  • projects with pharma, biotech , Medical Device and CRO companies
  • international monitoring experience
  • languages: French  , dutch and English : fluent
  • regulatory and Ethics submissions in benelux + france
  • ha inspections and sponsor audits experiences
  • driving licence (monitoring in benelux)
  • skilled in word-xls-ppt
  • gcp accredited
  • central located in belgium (near brussels)

 

 

Experiences

Current Experience

  • Freelance Senior Clinical Research Consultant

    Meise/ Vlaams Brabant
    Since April 2014

    Freelance Clinical Research Consultant as scra more than 17y experience in the clinical research Operations (national and international monitoring): scra experience from feasibility, start up , monitoring , close outs until end of clinical activities ec and regulatory submissions in benelux, france and switserland phases i (first in human, dose escalation, dose expansion; mainly in oncology) - Phase II - iii - iv - pass - paes - registries disease areas experiences are : °oncology ( lung Cancer, breast Cancer, gastric, colorectal cancers, urologic cancers...) °hemato-oncology (lymphomas, leukemias), °rare diseases (as cutaneous lymphomas, systemic mastocytosis, tuberous sclerosis , fabri disease.. ) °CNS (ms, stroke, parkinson, huntington, alzheimer, dementia..).. °Psychiatry (depression, psychosis)) °Cardiology (af), Vascular surgery (Medical Device ) °Endocrinology, °Rheumatology (arthrosis; Medical Device)...

    Freelance Clinical Research Consultant as sCRA More than 17Y experience in the Clinical Research Operations (national and international monitoring): sCRA experience from feasibility, start up , monitoring , close outs until end of clinical activities EC and regulatory submissions in Benelux, France and Switserland Phases I (first in human, dose escalation, dose expansion; mainly in oncology) - Phase II - III - IV - PASS - PAES - registries Disease areas experiences are : °Oncology ( lung cancer, breast cancer, gastric, colorectal cancers, urologic cancers...) °Hemato-oncology (lymphomas, leukemias), °Rare diseases (as cutaneous lymphomas, systemic mastocytosis, tuberous sclerosis , Fabri disease.. ) °CNS (MS, Stroke, Parkinson, Huntington, Alzheimer, dementia..).. °Psychiatry (depression, psychosis)) °Cardiology (AF), Vascular surgery (Medical device ) °Endocrinology, °Rheumatology (Arthrosis; medical device)...

Past Experience

  • Clinical Research Manager Benelux

    March 2011 --- May 2014

  • CRA Manager

    February 2011 --- March 2011

  • Data Reviewer (Ad Interim)

    September 2010 --- January 2011

  • Clinical Research Manager Benelux (Ad Interim)

    May 2010 --- August 2010

  • Clinical Research Associate (CRA)

    May 2008 --- April 2010
    CRA with Project Management activities on international projects. coordination of CRO's working on novartis globally outsourced projects.

  • Clinical Research Associate/project manager - EMEAC countries

    September 2006 --- April 2008

  • Secretary

    January 2002 --- January 2006

  • Clinical research coordinator in neurology

    January 1998 --- January 2006

Personality

Self Assessment :
Analytical thinkingAttention to detailEfficiencyIndependenceProblem solving

Knowledge

Self Assessment :
Cardiovascular diseases Medical devicesClinical monitoringClinical operationsClinical trial budgetingCTMSContract negotiationEndocrinologyEthics submission and approval processGastroenterologyGCPHematologyInfectious diseasesMicrosoft ExcelMicrosoft OfficeNeurologyoncologyPhase IIPhase IIIPhase IVUrology Phase IAdverse Events (AE)BiologyBudget NegotiationCAPACell biologyClinical researchClinical Trial Management System (CTMS)CNSCROeCRFEndocrinology and metabolismEnglishGynecologic oncologyICH guidelinesInformed Consent ProcessMolecular geneticsNeuroscienceOncology Clinical ResearchPowerPointPsychiatryRheumatology
LinkedIn Assessment :
Clinical trialsClinical researchNeurologyoncologyClinical trial managementNeuroscienceGCPEDCMedical DevicesCROClinical DevelopmentCTMSICH-GCPPharmaceutical IndustryClinical monitoringTherapeutic AreasRegulatory submissionsPharmacovigilanceRegulatory affairsClinical Research AssociatesSOPClinical Data ManagementPeople SkillsSOPCardiologyClinical operationsEndocrinologyRheumatologyLife SciencesBiotechnologymanagementData ManagementCAPA

Skills and Expertise

Self Assessment :
Analytical skills Monitor a clinical studyConduct site initiationConduct studies

Education

  • in from Vrije Universiteit Brussel in 0000
  • in from VUB / ULB in 0000

Training and Certification

  • GCP Accreditation in 2017 Certification
  • Master in Sciences in 0000 Certification

Languages

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

Work Preferences

  • Positions I am interested in:
    Senior Clinical Research Associate (CRA)
  • Positions I am NOT interested in:
    Project Manager
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    BrightOwl freelancer
  • International:
    Yes
  • Availability:
    Jan 2018 : 50%
    Feb 2018 : 50%
    Mar 2018 : 50%
    Apr 2018 : 80%
    May 2018 : 80%
    Jun 2018 : 80%

Area / Region

Meise/ Vlaams Brabant

Others

Driving License
  • Yes

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