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Summary

i am currently a Clinical research Trainer. i am providing open and tailored courses on clinical Project Management, Risk Management, risk based monitoring, advanced Project Management, MS Project, gcp etc. my experience as CRA and Project Manager (global and local pm) is helping me a lot during trainings.

i am now looking to new opportunities either in Training or as line manager for CRA and/or pm. indeed my background and all i learned as Trainer will for sure help me to better manage a team.

Experiences

Current Experience

  • Trainer and coach

    Brussels, Belgium
    Since March 2015
    • Developing and providing Clinical Operations training for public courses and tailored courses as Clinical Project Management, Risk Management in Clinical Trials, Risk Based Monitoring, Advanced Project Management, Ms Project basics, Working with CROs, ICH-GCP, CRA trainings etc
    • Development of eLearnings and blended learnings
    • Development of Competency Framework internally and for clients
    • Development of team building programme
    • External trainers mentorship

Past Experience

  • Project Leader

    June 2014 --- March 2015
    be the main contact for the sponsors global study management from study set-up until closing. CRA work review and management.

  • Project Manager

    October 2013 --- May 2014
    management of Clinical trials in belgium and the netherlands. be the main contact for investigators and cras.

  • Global Study Leader - Immunotherapeutic (Oncology)

    December 2012 --- October 2013
    - be the reference for study management - interact with project team, senior management (core team…) and all internal (dm, gvcl, drug supplies team …) and external (providers, CRO…) stakeholders involved in the project(s). - delegate, coordinate and follow-up country specific activities and /or process specific activities …) of the project(s) within a team of gsm(s). - plan, organize, analyze, evaluate and improve (if applicable) of all operational aspects (countries selection, feasibility, recruitment of subjects, Data Management, budget, etc) of one large and complex project.

  • Global Study Manager - Immunotherapeutic (Oncology)

    March 2010 --- November 2012
    - management of studies (Phase II & Phase III, standard or non-standard project, collaborative, multi country) according to ich gcp guidelines. acting as the reference person for all operational/monitoring related issues for studies between the central functions and the local actors of the studies and coordinates the operational aspects of a Clinical study from start to end.

  • Clinical Research Associate (CRA)

    June 2006 --- March 2010
    Clinical trials monitoring in oncology and pediatric in accordance with the ich/gcp guidelines, the current monitor guidelines including identifying sites, preparing Documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring visits at sites, reporting visits and contacts with sites, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting case report forms, following up and solving data queries, reporting the progress of the study on a regular base and performing site close-out visits.

  • IVRS Project Manager

    March 2003 --- June 2006
    set-up and leading of ivrs projecs for Clinical trials (Phase I, ii and iii studies) - design of the ivrs in collaboration with Pharmaceutical companies: contact with sponsors pm, development of relationship between different partners, etc. - technical specification plan, ivrs Documentation, scenarios and database set-up - conferences: presentation of ivrs to the Clinical Trial’s partners - management of clinical trails and the ivrs Databases - concerted work with Medicine and sponsor’s project team - management of treatments’

  • Researcher in Ovarian Virology Laboratory

    March 2000 --- October 2002
    sstc Researcher on the project “etude des mécanismes d’immunosuppression chez le poulet, utilisant la maladie de gumboro comme modèle” .

  • Researcher in R&D department

    October 1998 --- March 2000
    Automation and development of new techniques to measure cytokines and hormones in human blood.

  • Researcher for FNRS (“Fonds National de Recherches Scientifiques”)

    April 1998 --- October 1998
    development of transgenic vector from retrovirus and parvovirus anticancer Vaccines based on dendritic cells studies about the cellular apoptosis

Personality

Self Assessment :
CommunicativeCoordinationCuriosityEfficiencyFlexibilityIndependenceInterest in knowledgeOptimismOrganizationProblem solvingResult OrientedResponsibilitySelf-confidenceSelf-disciplineSociability

Knowledge

Self Assessment :
TrainingRisk ManagementRisk Based Monitoring Biochemistry Negotiation21 CFR Part 11Adverse Events (AE)BiopharmaceuticalsBudget Management Phase ICancerCancer ResearchCAPAChemistryClinical Data Management (CDM)Clinical monitoringClinical DevelopmentClinical operationsClinical researchClinical SuppliesClinical trial audits and inspectionsClinical trial budgetingClinical trial managementClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCommunication SkillsComplianceCompliance with regulationsContinuous ImprovementCRFCRF designCROCross-functional team leadershipCTMSDatabasesDNADrug AccountabilityElectronic Data Capture (EDC) ELISAEMAEnglishEthics submission and approval processFDAForecastingGood Clinical Practice (GCP)Good Distribution Practice (GDP)Good Manufacturing Practice (GMP)ICH guidelinesInformed Consent DocumentsInformed Consent ProcessInternational Project ManagementIVRSLeadershipMicrosoft OfficeMS ProjectoncologyOncology Clinical ResearchOutsourcingPatient recruitmentpeople managementPhases of clinical development (phase I to IV)Presentation SkillsProject CoordinationProject Management
LinkedIn Assessment :
Clinical researchOncology Clinical ResearchIVRS - Randomisation and drug supplyClincal trial Phase II-IIIClinical trialsoncologyVaccinesICH-GCPSoftware DocumentationGCPCTMSClinical DevelopmentPhase IClinical monitoringEDCRegulatory submissionsCROProject ManagementCancer ImmunotherapyPharmaceutical IndustrySOP

Skills and Expertise

Self Assessment :
Work collaboratively with the other members of the clinical research team team management Guide students Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdjust processes Administer, maintain and co-ordinate the logistical aspects of clinical trialsTrain StaffDevelop training materialsProvide training

Education

  • Master's degree in Biochemistry from Université libre de Bruxelles in 1997
  • in from Decroly in 0000

Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Operations Manager Clinical Research Manager Trainer Team Leader line manager
  • Locations I am interested in:
    Brussels, Belgium
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    90% FTE
    BrightOwl freelancer :    8 Hours per week
    BrightOwl employee :    90% FTE
  • International:
    Yes
  • Availability:
    Sep 2018 : 20%
    Oct 2018 : 20%

Area / Region

Bruxelles, Belgique

Others

Driving License
  • Yes

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