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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