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Summary

  • Profound understanding of clinical research (healthy volunteers up to phase 3) and solid knowledge of regulations (EU and US)
  • Project Management Skills
  • Experience working in oral mucositis (head and neck cancer), inflammatory bowel disease, cardiology, deep vein thrombosis/pulmonary embolism, oncology, liver disease, diabetes and insomnia
  • Experience in vendor oversight with focus on CRO management
  • Ability to effectively and proactively manage, in a team or independently, multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Ability to lead a cross-functional team in a matrix environment
  • Negotiation skills
  • Excellent presentation and communication skills
  • Speaker at congresses/conferences
  • Problem solving capability through early identification

Experiences

Current Experience

  • Clinical Project Manager (CPM) Zwijnaarde, Gent, België
    Since February 2008

    • Responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects and clinical studies (healthy volunteers up to phase 2 studies) ensuring consistency with company strategy, commitments and goals
    • Execute and finalize projects/clinical studies according to strict deadlines and within budget
    • Coordinate the efforts of team members and vendors or consultants in order to deliver projects/clinical studies according to plan
    • Provide overall efficient day-to-day management of the projects/clinical studies
    • Guarantee that the work within the clinical programs is in accordance with ethical, regulatory and safety guidelines and following the Company SOPs
    • Evaluate and select external partners for both toxicology and clinical studies
    • Review and co-develop documents required for clinical development: CTAs, clinical study reports, protocols, investigators brochures, IMPDs, application forms, informed consent forms, abstracts, publications…
    • Set up and implement a Quality Management System for the execution of clinical studies
    • In collaboration with Regulatory Affairs, interact with competent authorities, EMA and FDA (scientific advice meetings) and contribute to the preparation and/or submission of CTA/IND as well as GMO deliberate release/contained use files & Recombinant Advisory Committee dossier (for US)
    • Participate in due diligence projects

Past Experience

  • Clinical Project Leader Brussel, België
    July 2004 --- January 2008

    • Study management activities (coordination and management of phase 2-3 clinical studies and staff), ensuring that timeframes and targets are met and that costs are kept under control
    • Monitor the quality specification within the project

  • Clinical Research Associate (CRA) Brussel, België
    October 1997 --- July 2004

    Site management activities (in house and on-site monitoring) according to ICH-GCP guidelines, FDA regulations and SOPs, lead CRA for certain studies

Personality

Self Assessment :
Attention to detailSelf-confidenceApproachabilityTrustCollaborationCoordinationCreative thinkingEfficiencyIndependenceProblem solvingStrategic thinkingAdaptabilityFlexibilityInterest in knowledgeOrganizationProactivitySociability

Knowledge

Self Assessment :
Monitoring Study ProgressProject ManagementPhase IIIPhase IIPhase IPharmacokineticsNegotiationMicrosoft OfficeKOL managementInformed Consent ProcessINDIMPDICH-GCPProtocolWriting Study Procedures and SOPsClinical study reportsFDASearch literature on clinical trialsEnglishCardiologyEMAOrthopedic surgeryoncologyRegulatory submissionsSupervising CRAsClinical Study DesignInformed Consent DocumentsGastroenterology NegotiationClinical trial budgeting R&DContract negotiationClinical trial managementClinical trialsClinical researchClinical operationsClinical monitoringClinical DevelopmentBiotechnology Phase I
LinkedIn Assessment :
Clinical trial managementICH-GCPClinical trialsClinical DevelopmentCTMSGMOClinical monitoringClinical operationsTherapeutic AreasBiotechnologyLifesciencesClinical researchCROoncologyDrug DevelopmentGCPLife Sciences

Skills and Expertise

Self Assessment :
Manage study budgetBuild trial master file (TMF) Monitor a clinical study Search literature on clinical trialsAdverse event reportingApprove monitoring reportsApprove queriesArchive study documentsAssess site feasibilityAssess subject safetyAssist study site CTMS Act as the main line of communication between the sponsor and the investigatorConfirm protocol compliancePatient recruitmentSelect contractors Solve problemsClinical data collectionCollaborate with project teamComplete study proceduresConduct close-out visitsConduct monitor visitsConduct the trialAssist with proceduresAttend investigator meetingDistribute trial suppliesCreate standard operating procedure (SOP)Create study documentsCreates a collaborative team environmentDesign clinical trialDesign exclusion criteriaDesign inclusion criteriaDesign protocolDesign subject consent formDevelop ICH/GCP compliant processesDevelop study timelinesDiscuss treatments with investigatorDistribute study documentsInteract with nursesDocument adverse eventsEnsure good clinical practice (GCP)Ethics committee submissionsGastrointestinal diseasesIdentify investigatorsIndentify sitesInformed consent processInitiation visitInteract with CROsInteract with ethics committeeDevelop study budgetSet up a clinical studyPresent data at congressPrepare internal auditsOrganise meetingsMonitor a clinical studyManuscript preparation and reviewManage vendor budgetsLiaise with research team

Education

  • Pharm D in from Katholieke Universiteit Leuven in 1996
  • Economy - Modern Languages in from Heilig Hart Instituut Harelbeke in 1991

Languages

BrightOwl Assessment:
Self Assessment:
Spanish
Elementary Proficiency
Dutch
Native
French
Full Proficiency
English
Full Proficiency
Italian
Elementary Proficiency
German
Elementary Proficiency

Work Preferences

  • Work From Home:
    Yes, 2 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Zwijnaarde

Others

Driving License
  • Yes