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Summary

9 years of successful experience in Clinical trials management of Drug Safety Adverse Events and Medical Devices complaints coordination of clinical studies strong knowledge of ich-gcp Training of people computer proficiency

Experiences

Past Experience

  • Global Vaccine Clinical Laboratory Study Manager, Expert Consultant Rixensart, Belgium

    January 2014 --- June 2016

    the Clinical laboratory study manager job consists of acting as a global operational point of contact for all gsk Vaccines stakeholders and contracted central laboratory study representative to coordinate any laboratory related activities of epidemiological and clinical studies (pi to iv) in standard and complex operational or regulatory environments.

     

    responsibilities:

     

    • at study level, pro-actively coordinate set-up & follow-up of operational laboratory related activities
    • review of all clinical study documents: Clinical Development plan, protocols, study procedures manual, crfs, Lab manual, notes to file, study risk assessments, science)" rel="nofollow">Protocol deviation forms, destruction requests
    • ensure operational processes are standardized between studies within a project
    • establish network of Communication and continuously build collaborations to facilitate smooth partnership between stakeholders
    • coordinate all laboratory related activities for allocated project (in-house and with external partners), review and discuss contracts
    • ensure daily deliverables and study milestones are respected, define and analyse kpis, identify trends and ensure problems are addressed
    • identify necessary process improvement to ensure sample management & laboratory output meet company standards, gcp-ich /gclp as well as project requirements
    • contributes to the Investigator/ monitor meetings by presenting and discussing the study objectives and procedures
    • assist local operating companies with regards to the management and monitoring of human Biological samples or any laboratory related activity according the gcp-ich, gclp and gdp

  • Data Management Consultant Rixensart, Belgium

    May 2012 --- January 2014

    the Data Management team is responsible for the management of all incoming modification files, Lab request changes and reconciliation forms

     

    responsibilities:

     

    • assist Clinical services team in process review (reconciliation, full study Outsourcing, central Lab source plan)
    • process with modification file/Lab request change in roxis (SAP-labware)
    • initiate, follow up on and solve investigations as back –up for reception team
    • import data from slp cross reference file (files coming from an external labs)
    • perform virtual reception for Biological samples into roxis

     

    achievements:

    • took the lead and became the Supervisor of the team
    • organized team meeting and set priority rules

  • EMEA Field Surveillance and Vigilance Specialist Braine-l'Alleud, Belgium

    August 2011 --- January 2012

     responsibilities:

     

    • manage products complaints in renal and medical delivery division in emea
    • determine meddev reportability and submit subsequent reports to the competent authorities
    • coordinate investigations activities and the related reporting requirements
    • identify and notify potential therapeutic product Adverse Events information to Pharmacovigilance units
    • identify trend according to corrective and preventive actions (capa) requirement
    • provide support and train local coordinators on procedures

  • Data Manager Consultant Waterloo, Belgium

    May 2009 --- July 2011

    responsibilities:

     

    • identify and solve data inconsistencies between items in the clinical database
    • review, verify data query answers and corrections in the database or implement corrections according to answers
    • organize and lead the post-cleaning meeting
    • issue the cleaning report and send final reports to different team members of the Clinical research study

     

     achievements:

     

  • Complaints Specialist Waterloo, Belgium

    May 2008 --- April 2009

    projects:

     

    i was the main representative of the complaint handling and safety surveillance team in europe

    the project consists on identifying all missed reportable complaints and resolving issues of collaboration between the complaint handling team based in the us and the clinical department team based in europe.

     

     

    responsibilities:

     

    • perform the initial reconciliation of Electronic Data Capture (edc) studies/registries
    • analyze reports from edc Databases to ensure that complaints are processed in accordance with established company procedures and worldwide regulations
    • resolve issues in collaboration with the Clinical research team in order to identify root cause and initiate Quality Management systems (qms)
    • responsible for projects related to the enhancement of the reconciliation process
    • provide general assistance to eu affiliate sites regarding complaint processes
    • provide Training to internal colleagues and external partners regarding complaint handling
    • participate in monthly complaint meetings and communicate with worldwide complaint groups

     

    achievements:

     

    • implementation of a solid reconciliation tool with the collaboration of the Clinical research team
    • Training material for local and external colleagues regarding complaint report process

     

  • External Lab Coordinator Rixensart, Belgium

    January 2008 --- April 2008

    responsibilities:

     

    • manage human blood samples
    • ensure samples are processed, stored, and shipped according to science)" rel="nofollow">Protocol requirements
    • receive Lab results and communicate with internal Lab collaborators

  • Clinical Project Assistant Wavre, Belgium

    October 2007 --- January 2008

    responsibilities:

     

    the main responsibility was to assist 4 project managers by providing study progress and tracking milestones and assure operational running of the project by collecting relevant info to different members interacting with the project

     

    • assure operational running of the project by collecting relevant info to different members interacting with the project
    • provide current issues, study progress, communicate and follow up on project tracking discrepancies
    • responsible for the monthly project tracking reports of budget payments, study budget breakdown signatures and project status
    • participate in project activities preparation, implementation and follow up
    • collect data, analyze and maintain all projects related database up to date
    • prepare financial reports and forecasts

  • Clinical Safety Associate Wavre, Belgium

    January 2007 --- September 2007

    projects:

     

    management of any Adverse Events and serious Adverse Events for hpv project

     

     

    responsibilities:

     

    • collect and review adverse event reports and identify clinically significant information and causality
    • ensure that reports are accurately coded in the database using terminology prescribed by global regulatory authorities and MedDRA safety dictionary
    • request pertinent information and follow-up reports from the appropriate reporter within specific timelines
    • assist in reconciliation of Clinical and safety Databases

     

     

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCoordinationOrganizationProactivityProblem solvingReaction to stressTrust

Knowledge

Self Assessment :
21 CFR Part 11Adverse Events (AE)CAPACardiovascular diseasesChange ManagementClinical Data ManagementClinical operationsClinical study reportsClinical trial managementClinical trialsCommunication SkillsContinuous ImprovementData cleaningData ManagementDrug Safety and PharmacovigilanceeCRFEDCEfficacy trialsElectronic Data Capture (EDC) Good Clinical Practice (GCP)GXPLifesciencesNutritionPharmaceutical IndustryPhases of clinical development (phase I to IV)Project CoordinationSafety reportingSAPStandard Operating Procedure (SOP)TrainingVaccines
LinkedIn Assessment :
ClinicalClinical trialsICH-GCPLife SciencesPharmaceuticalsEpidemiologyVaccinesGCPProject CoordinationCross-functional CoordinationProject ManagementClinical Data ManagementQuality AssuranceMedical DevicesPharmacovigilanceDatabasesEDCAnalysisCompliance

Skills and Expertise

Self Assessment :
Analytical skills Report dataAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAssist with proceduresAttend investigator meetingCoach staffCommunicationConduct studiesCoordinate projectsCoordinationEnsure good clinical practice (GCP)Interact with CROsManage multiple projectsProvide trainingSet up a clinical studyWrite final reports

Education

  • Post-graduate programme in Pharmaceutical Medicine & Drug development Sciences in from Pharmed in 2012
  • Advanced training in Data management from Biowin in 2010
  • Advanced training in Administrative Assistant and Secretarial Science, General from Bruxelles Formation in 2005
  • Bachelor in Biochemistry from Institut R. Lambin in 0000

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
LINGALA
Native

Work Preferences

  • Positions I am interested in:
    Clinical Trial Specialist (CTS) Clinical Trial Manager (CTM) Clinical Research Consultant Clinical Trial Coordinator (CTC) Clinical Research Coordinator Clinical Project Manager (CPM) Clinical Data Reviewer Clinical Operations Manager Clinical Research Manager Clinical Trial consultant CRM CTA Manager Data Manager Data Reviewer Field Clinical Specialist Global Clinical Project Manager (GCPM, GTM) Global PM
  • Locations I am interested in:
    Brussels, Belgium London, United Kingdom Switzerland Walloon Brabant, Belgium
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

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