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Summary

my Career started 15 years ago with a master in Biology followed by a first experience in Research over 6 years in different universities in namur, gembloux and montréal (canada) and one year of Scientist and commercial Consultant for a spin-off called biosiris. 8 years ago, to discover new perspectives, i started to work at the opposite of the basic Research to go into the Clinical trials environment. starting as CRA in belgium, i grew in this position by doing different trials from phases i/ii to iv working for different sponsors in france and in the netherlands in different Therapeutic Areas with most of my experience made in oncology. in parallel of this CRA role, i had the chance to start quickly to coordinate some Clinical trials which pushed me to stop the monitoring role to be fully dedicated to the management of Clinical trials. it brings me today to be study delivery manager within gsk for international projects Phase I-ii coordinating 8 countries in europe, us and asia. working at the sponsor gives me the possibility to participate to some Strategy discussions and development of some documents like science)" >Protocol, icf, crf (+Data Management plan), ivrs plan, budget, metrix development, etc….. my main motivation is in this role to gather different countries to have a high standard of quality to be able to deliver our objectives in due time. moreover this position brings you at the center of all the stakeholders within the company which is very enriching due the varied topics discussed in the scope of a Clinical Trial. my expectation of Career development is to grow into Project Management activities linked to Clinical trials and Pharmaceutical Industry. with this experience varied from CRA within a CRO to a coordination position within a sponsor, i have a good view of the different stakeholders involved in the Clinical trials and i think that i’m able to interact and communicate with them on an efficient way to bring a good quality for my employer.

Experiences

Current Experience

  • Senior Project Manager


    Since April 2016

Past Experience

  • Project Manager

    May 2015 --- March 2016

  • Clinical Project Manager (CPM)

    November 2014 --- May 2015

  • Study Delivery Manager Rixensart

    January 2011 --- October 2014
    here are the main responsibilities of the function: • to ensure the operational aspects of the studies and to deliver according to the plan • to have a good oversight of all operational aspects of a study from the setup to the closure • to coordinate different countries & local managers to ensure a good oversight • interaction with different stakeholders to ensure study delivery on time with a good quality • to have a good Project Management mindset by managing the budget, the timelines and Risk Assessment • to be involved in process improvement, developing of new tools, developing of metrics, review of guidance and documents (icf, science)" rel="nofollow">Protocol, manuals,…)

  • Clinical Research Associate (CRA)

    September 2008 --- January 2011
    performing of monitoring for Phase II-iii in belgium, france and netherlands for international oncology projects. site selection, feasibilities and Qualification visits in belgium and netherlands.

  • Clinical Study Nurse (SN)

    January 2008 --- September 2008
    coordination of Phase II trial between 10 different countries, coordination cras, interaction with sponsor, assistance for submissions, participation to the Strategy and management, coordination of all the Documentation between site/CRA/sponsor, monitoring according science)" rel="nofollow">Protocol, gcp and SOP

  • Clinical Research Associate (CRA)

    May 2006 --- January 2008
    monitoring Phase II, iv trials, initiation visits, close out in belgium and france. preparation science)" rel="nofollow">Protocol Phase III, resolution of queries, site selection, preparation of internal and external audits, Trainer, Translation regulatory documents, assistance to other harrison affiliate, participating to international trials

  • Scientist and commercial consultant

    January 2004 --- December 2004
    development of spin-off in bio-informatic look for potential client, representation in different events, congress, international trade fair with one to one. development of consultancy material identification of product catalog scientific follow up of client request development of scientific tool in bio-informatic in collaboration with the University of gembloux

  • researcher

    September 1999 --- December 2004
    Research in bioinformatic: prediction 3d structure, Proteins sequence analyses, insertion of 3d models in a model of hydrophobic membrane, interaction Peptides/membranes, comparison patterns of Proteins. alzheimer disease, Cancer, parkinson. participation to different Publications and book chapters

Personality

BrightOwl Assessment :
OrganizationDiligenceCuriosityPerspectiveDependability
Self Assessment :
AdaptabilityAttention to detailTrustSociabilityIndependenceEfficiency

Knowledge

BrightOwl Assessment :
FrenchdutchEnglishLife SciencesTeamworkClinical trial designPhases of clinical development (phase I to IV)Scientific methodologyClinical monitoringGood Clinical Practice (GCP)
Self Assessment :
Medical oncology Allergy and immunologyGastroenterologyHematologyOrthopedic surgeryGeneral surgeryDrug development processData entryClinical trial designICH GCP guidelinesDesigning case report formsPhases of clinical development (phase I to IV)Randomization and blindingPrinciples and ethics of clinical researchInformed Consent ProcessEthics submission and approval process
LinkedIn Assessment :
oncologyGCPLife SciencesPharmaceuticalsSOPCancerClinical researchClinical trialsClinical trial managementClinical monitoringCROClinicalClinical DevelopmentCTMSPharmaceutical IndustryProtocolICH-GCPSOPLifesciences

Skills and Expertise

BrightOwl Assessment :
Act as the main line of communication between the sponsor and the investigatorAnswer, transfer and handle incoming calls as needed. Build and manage the Trial Master File (TMF)Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Design the studyLiaise with doctors and other professionals throughout the studyParticipate in meetings with sponsors, monitors and regulatory authorities, as necessary.Plan work to meet objectives and deadlines
Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsassess operational feasibility and recommend study execution planAssess subject safety during trialattend Investigator meetings requiring travel and report pertinent information back to research team members.Build and manage the Trial Master File (TMF)Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Contact potential patients and schedule trial visitsDesign a tracking systemDesign the studyDesign case record formsDetermine availability of facilities and equipment at the siteWork with coordination and data management teamsEnsure consistency between the protocol and CRFInitiate clinical trials

Education

  • DEA in Biological Engineering from in 2001
  • in pharmacy from Université du Québec à Montréal in 1999
  • D.E.S in Applied biology from in 1999
  • in Biology from in 1998

Training and Certification

  • Full week of Dutch Course in 2014 Training
  • Working and communicating with Japanese colleagues or clients in 2013 Training
  • Managing the others in 2012 Training
  • Communication skills in 2006 Training
  • GCP in 2014 Certification
  • Project Management Essentials course in 2011 Certification
  • Clinical Research Training for Senior CRA in 2008 Certification

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Nivelles

Others

Driving License
  • No

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