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Summary

25+ years of experience in the oversight, management and conduct of international phase II – IV trials running in EU and US. Management of clinical operations teams in Northern Europe (Benelux, France, Denmark). Extensive experience in pain trials (low back pain, osteoarthritis, diabetic neuropathy, bladder pain syndrome), pain in children.

Experiences

Past Experience

  • Global Operations Study Leader
    December 2012 --- December 2016

  • Regional Head Clinical Development Operations Northern Europe
    September 2010 --- December 2012

  • Lead Clinical Operations Northern Europe
    July 2009 --- September 2010

  • Clinical Study Manager Benelux
    July 2007 --- July 2009

  • Clinical Study Manager Belgium
    November 2001 --- July 2007

  • Project Leader e-trials
    February 2001 --- November 2001

  • CRA, Senior CRA, CRA coordinator
    July 1991 --- February 2001

  • Product Manager
    January 1989 --- July 1991

  • researcher
    June 1986 --- January 1989

Knowledge

Self Assessment :
Writing Study Procedures and SOPsUnderstanding of regulatory guidelinesTeam ManagementTeamworkTeam LeadershipSupervising CRAs
LinkedIn Assessment :
Clinical DevelopmentClinical trialsProject ManagementCross-functional team leadershipPain ManagementCoaching & MentoringGood Clinical Practice (GCP)CRO managementPharmaceutical IndustryClinical Trial Management System (CTMS)Diary ManagementCRF designMicrosoft Office

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingApprove consent documentsApprove Label Master SheetApprove monitoring reportsArchive documentationApprove patient informationAssess site feasibilityAssign activitiesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist study siteWritten presentationWrite documentsWork with coordination and data management teamsWork cross-functionallyWork collaboratively with the other members of the clinical research team Update Clinical Trials Management System (CTMS) Understand protocolsTranslate strategy into operational plansTrain StaffTrain on site staffTrain off site staffSupport due diligence assessmentsSupervise clinical monitorsStudy-related documentsStudy execution planSolve problemsSite managementShipment of biological specimenSet up a clinical studySelect sitesSelect investigatorsSelect contractors Design case record formsAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyCalculate timelines for conducting and completing the trialCapture data on source documentsCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate effectively on different company levelsConduct site initiationConduct studiesConduct close-out visitsCommunicate with investigator Analyze dataContract approvalContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.control different protocol versions and other essential documentsCoordinate projectsCreate clinical project documents according to the protocolCreate SOPsCreates a collaborative team environmentData verificationDesign tracking systemDevelop ICH/GCP compliant processesDevelop strong internal relationships with stakeholdersDevelop study budgetDevelop study metricsDevelop supply plansDevelop training materialsDevelop study timelinesDistribute study documentsDistribute trial suppliesDocument employees training requirementsEnsure consistency between the protocol and CRFEnsure data integrityEnsure good clinical practice (GCP)Ensure data consistencyEstablish professional relationships with partnersEstablish contractsEthics committee submissionsFeasibility analysis of proposed trial designFacilitate sponsor monitoring visitsFollow-up of Quality Management System (QMS) processesIdentify and provide training to trial team and associated staffIdentify investigatorsIdentify risksImplement Key Performance Indicators (KPI's)Indentify clinicians to conduct clinical trialsInformed consent processInitiate clinical trials Interact with CROsInteract with ethics committee

Education

  • in Degree in Applied Medical Biology, Faculty of Medicine from Free University of Brussels, Belgium in 1986

Languages

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

Work Preferences

  • Positions I am interested in:
    Global Clinical Project Manager (GCPM, GTM)
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 2 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes