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Summary

I am a senior trilingual study manager with CRA experience at the sponsor and the CRO. I gained experience in all phases and stages of a clinical study in different domains: from the development, start up, enrolment, conduct until reporting of global phase I to III research and therapeutic studies. I take leadership and promote an open communication across the international team of CRAs/CTAs, team/project members, vendors and sponsors to ensure high quality performance, completion of the project within the timelines and budget. My role as Local Training Representative confirms my coaching skills. I have a drive for results and work with passion. I am currently looking for new challenges.

Experiences

Current Experience

  • Training Representative
    Since November 2013
    Coordinate all country-specific training, act as an advisor to the department on training needs and processes, deliver training when appropriate and liaise with the Training and Development Department. Key areas of Responsibility: • To arrange country-specific training and co-ordinate SOP training for the local office. • Understand and advise on local training needs (including audit findings) and how to address them. • Ensure accurate and complete Training Records, including line manager’s review and quality control checks, for the local office. • Identify improvements and escalate issues.

  • Clinical Team Leader
    Since June 2013
    Provide functional leadership to a defined group of Clinical Monitoring staff working on a designated project to ensure high quality performance and completion of the project within the timelines. Key areas of Responsibility: • Co-ordinate the development and communication of study start-up plans and project-specific procedures, guidelines, documents and forms, in line with relevant SOPs, ICH/GCP and local requirements. Oversee the collection of regulatory documents and submission to the EC/IRBs. Supervise the shipment of study supplies to the sites. • Conduct feasibility assessments, review recruitment status and recommend actions and implement actions if recruitment status is not on target. • Ensure the performance of the Clinical Monitoring project team against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements. • Ensure that all study related activities are being conducted according to study requirements, relevant SOPs, guidelines and regulations. • Act as the reference person for all operational/monitoring related issues. • Set priorities and ensure deadlines are maintained.

Past Experience

  • Global Study Manager
    November 2011 --- June 2013
    Manage all types of studies (Phase I to Phase III, standard or non-standard project, collaborative, multi country) according to ICH GCP guidelines and GSK policies and SOP’s to ensure the quality of the study data in order to use them in registration dossiers submissions to regulatory authorities. Act as the reference person for all operational/monitoring related issues for his/her 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. Analyze and evaluate the feasibility and consequences of design proposed in regards to procedures, consult other departments (double blind lots…), other teams (DM, …) and with the countries for the monitoring. Ensure necessary specific user-guide is prepared on time (CRF completion guidelines, manual cleaning guidelines, Investigator laboratory manual...). Sign-off of essential documents (protocol, CRF, ICF, primary SR, report). Propose, organize and lead monitors meeting, to transfer knowledge and study specific training in order to ensure the highest quality standards. Assess need for and propose co-monitoring visits in countries or do co-monitoring upon request. Delegate work to CTA and/or Global Study Coordinators of his/her project and coach him/her depending on expertise. Actively participate and represent the Global Study Management function, taking into account the need of peers/other projects, in internal process improvements as well as training on their specific taskforce, including presentations at GSM meeting, workshop, SOP session, Inv/monitors meeting.

  • Global Study Manager at GSK Biologicals
    September 2009 --- November 2011
    Provide operational input in the study design, planning, organisation, analysis and evaluation of clinical studies.

  • Senior Clinical Research Associate Oncology
    January 2008 --- September 2009
    Coordinate a defined group of CRAs working on a designated project and act as a CRA to ensure study set up, high data quality collection and complete the study within the timelines.

  • Clinical Research Associate Oncology
    June 2007 --- December 2007
    Ensure study set up, high data quality collection and complete the study within the timelines.

  • Clinical Research Associate at GSK Pharma Oncology
    June 2006 --- May 2007
    Ensure study set up, high data quality collection and complete the study within the timelines.

  • Clinical Project Assistant at GSK Pharma
    December 2004 --- May 2006
    Provide administrative support for (senior) Clinical Research Associates.

Personality

Self Assessment :
IndependenceAuthenticityTrustApproachabilityWillingness to compromiseOptimismOrganizationSelf-disciplineEfficiencyAttention to detailSociability

Knowledge

Self Assessment :
Gynecologic oncologyAllergy and immunologyNeonatologyPediatricsPulmonary diseasesDrug development processClinical trial designPhases of clinical development (phase I to IV)Randomization and blindingCell biologyDNA sequencingProtocolsciencemolecular biologyMultilingualTeamworkClinical DevelopmentClinical monitoringGCPICH-GCPVaccinesPharmaceutical IndustryCROClinical trialsPharmacogenomics (study of genetic variation)Principles and ethics of clinical researchICH GCP guidelinesEthics submission and approval processInformed Consent ProcessInformed Consent DocumentsMonitoring Study ProgressProject ManagementManaging Clinical Trial SuppliesPatient Screening and RecruitmentPatient Follow UpClinical trial audits and inspectionsPhase IPhase IIPhase IIIClinical research
LinkedIn Assessment :
oncologyInformaticsCROGCPClinical trialsClinical monitoringICH-GCPClinical DevelopmentClinical researchPharmaceutical IndustryVaccinesCTMSElectronic Data Capture (EDC) SOPProtocolTherapeutic Areas

Skills and Expertise

Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsArchive trial documentation and correspondence.Assign, coordinate and supervise day-to-day activities of clinical study monitorsAttend seminars, courses and meetings within and outside the companyCalculate 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.Create clinical project documents according to the protocolDevelop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsR&DWork collaboratively with the other members of the clinical research team Supervise and/or distribute trial supplies, including the trial drug Review and approve monitoring reports, track ongoing issues and query resolutionperform Data verificationIndentify, meet, interview and persuade investigators to conduct clinical trialsDetermine availability of facilities and equipment at the siteIdentify site issues and initiates correction plans based on monitoring reports.

Education

  • Basiskennis Bedrijfsbeheer in from Syntra, Leuven in 2009
  • Getuigschrift Pedagogische Bekwaamheid in from GroepT in 2006
  • Master in Biology from Vrije Universiteit Brussel in 2004

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    No

Area / Region

Wilsele

Others

Driving License
  • Yes