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Summary

- flexible and open-minded - handle independently - thrives under pressure - well-organized and able to determine what has priority. - highly Customer Service - always prepared to learn - open-minded for new opportunities

Experiences

Current Experience

  • Logistics and buying coordinator


    Since April 2014

Past Experience

  • Project Coordinator/Clinical Data Monitor

    October 2013 --- June 2014
    - sets up the related project master files for administration. - contributes in the set-up and monitoring of new Research Assays which require extra attention and a flexible approach. - ensures adequate Communication with the Data Manager regarding sponsor/client specific Data Management questions and set up. - ensures adequate Communication with sample reception for the preparation of new assigned janssen Diagnostics bvba projects. - sets up start-up meetings to inform all in-house staff on upcoming janssen Diagnostics bvba projects. - is first point of contact for all janssen Diagnostics bvba dedicated projects and maintains client satisfaction. - ensures blinding/un blinding methods are strictly adhered to, if applicable. - ensures follow-up and reporting of all Research (ruo) datasets and non-Research data sets (validated). - is responsible for the initiation of work orders and makes sure all ruo samples are started in our Lab process, according to client agreements. - works closely with the Lab to continuously align Lab capacity with client expectations. - aligns with the Lab on a daily basis for priority setting. - ensures that agreed turn-around-times (tat) for result reporting is respected. if needed, clarifies reasons for sample Analysis delays and/or takes pro-active measurements. - sends or ensures sending of Laboratory result reports or Laboratory results. - ensures return of destruction of stored/archived specimens. - ensures final invoicing. - prepares project overview reports for departmental meetings. - keeps track of timelines for projects. - reports any issues related to the services offered to the hierarchical Supervisor. - creates monthly kpi overviews for evaluation of Lab performance. - ensures confidentiality of patient related information (data privacy). - if applicable, acts as back-up for the data information manager (dim). - ensures application of all policies, SOP’s, wi’s and other guidelines - etc...

  • Project Management Assistant

    December 2011 --- August 2013
    - preparing investigators meeting presentation - placing initial supplies and managing re-orders - liaison for daily questions iss/Lab/scm/Logistics: follow-up with the departments on daily questions and help the pm with managing email Communication. - gathering all Documentation required for regulatory submissions and import/export license - attending smaller Investigator meetings when pm availability is an issue - prepare Documentation and binders for audits - following up at study closure - assistance on managing/reviewing listings that are required based on study specifics - assistance in reviewing and creating site deliverables - backup attendee for tc’s when the pm is out of the office - attend meetings and Training and make meeting minutes - assisting in budget revieuws and monthly invoices - providing the necessary documents to complete all site addresses ...

  • Investigator Services Assistant

    April 2009 --- November 2011
    • handling incoming calls from sites/CRA’s • handling problem samples • working with sys2000 for old studies • working with connexion for new studies • close exception and refaxed open exceptions • handling daily qc for old studies • reviewing dm listings and make corrections • clean the database in sys2000 and connexion for study closures • follow up daily connexion reports • handling vav’s ...

  • Data Coordinator/Administrator Assistant

    May 2006 --- March 2009
    • handling incoming calls from sites/CRA’s • handling problem samples • working with sys2000 • handling daily qc for incoming samples • reviewing dm listings and make corrections • clean the database (sys2000) for study closures • handling incoming reception calls • welcome visitors • filing • entering site/CRA information • refax failing faxes • handling vav’s ...

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryClinical trialsAdministrative AssistantsProject ManagementClinical researchProcess improvementDocument ManagementSOP developmentDashboardData ManagementICH-GCPICH guidelinesWork InstructionsTeleconferencingDigital ArchivingEmail ArchivingFile ArchivingQuality Control (QC)clinical dataInvoicingMeeting SchedulingLeading MeetingsInvestigatorsCAPAClinical monitoringStart-upsClosuresTurn Around ManagementDestructionCognosHermesHCVHIV

Education

  • High School in Youth and disabled care from Sancta Maria Leuven in 2004

Area / Region

Langdorp, Belgium

Others

Driving License
  • Yes

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