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Summary

8 years experience in Clinical Research as Clinical Trial Assistant having worked for Pharmaceutical Companies as well as CROs.

Main competencies: Organized, adaptable, pro - active, patient and a team player.

Experiences

Past Experience

  • Clinical Trial Assistant
    February 2014 --- November 2015

  • Senior Clinical Trial Assistant
    October 2012 --- June 2013
    • Provide overall administrative support to designated Project Managers & Clinical Trial Managers. • Write Minutes of weekly Sponsor and team calls • Responsible for TMF set up and update. • Maintain Essential Documents Tracking Database, eTMF and CTMS • Mentoring and training of Clinical Trial Assistants • Responsible & update TMF Tracker. • Preparation of Expenditure Authorization Forms for payment. • Responsible for maintaining Essential Documents Tracking Database ( ELARA) • TMF Audit and tracking. • Provide overall administrative support to designated Global Trial Leaders. • Responsible for Global Archiving with CTA Manager and Quality Insurance Manager. • Working with new Pfizer TMF (PTMF) for archiving documents concerning all transitioned studies. • Other databases used by Pfizer: Righttrack, Webtop, eSOP portal, shared documents, archivage,Power to Learn (SOP Portal) • Compile submissions to the Ethics Committee and Local Regulatory Agencies & translate for Global use. Amendment forms, CTA forms. • Activate sites using CTMS tool (before SIV’s) • Phase 1 study, feasibility, organization of Investigator meeting, contact potential sites for study. • Preparing contracts/ Conventions for Investigators, Hospitals, Coordinators, Anapaths/ Radiologists, Experts. • Declaration of Associations using the Statusthec. • Translation of CVs into English format and storage onto the Clinical Database • Filing electronically & manually Essential documents in the filing cabinets • Compile documents for Study files and coordinate with vendors for printing and shipment to sites

  • Clinical Trial Assistant
    February 2010 --- September 2012
    • Activate sites using xPress tool (before Investigational Products shipments) • Updating of Essential documents tracker using eTrack tool • Filing electronically & manually Essential documents in the filing cabinets • Preparation & shipment of required SIV documents to Hospitals & Pharmacies in France or abroad • Contact the Hospital Directions and sites as required • Activate the PI’s Associations into the Electronic system (for investigators fees payment) • Enter information into eRoom system & update Global enrollment in studies. • Send information monthly to Clinicaltrials.gov concerning site statuses... • Maintain study newsletters and use a Microsoft Publisher. • Order supplies for sites for the studies using Nowprint system... • Update trackers with patient recruitment information, study team Rosters, study team trackers • Provide Webex trainings concerning filing to other global CTA’s

  • Project Assistant
    April 2006 --- January 2010
    • Create and maintain project files and documentation • Responsible to maintain study status tracking forms, trial supplies dispatch and receipt records • Assist CRAs and third party vendors with patient travel reimbursement • Provide overall administrative support to designated Project Managers and CRAs • Write Minutes of weekly Sponsor and team calls and minutes of Investigator Meetings • Ensure efficient communication and professional telephone interaction with investigators and clients • Manage the administrative preparation for trial set up, monitoring, tracking and close out • Coordinate travels • Assist Start-up group in preparation of Regulatory and Ethics Committee packages. • Responsible to maintain tracking databases (e.g. CTMS) • Collaborate to Audit process. • Attend Site Visits and Investigator meetings

  • Collaborator of the Counsellor for the Ambassador
    October 2002 --- March 2006
    • Primary contact for the French Ministry of Foreign Affairs • Collaborate with French Customs and Malawian Government • Maintain International relations for UNESCO and United Nations • Translate all official documents from French to English • Manage the local Embassy staff of six persons • Organize all Embassy events • Attend diplomatic receptions on behalf of the Ambassador • Responsible for accommodations of Ministers and Government staff • Negotiation of contracts for Investments in Malawi with France

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCollaborationCommunicativeCompetitivenessCoordinationCreative thinking

Knowledge

LinkedIn Assessment :
Infections/Parasitic Disease: Chronic Hepatitis B Oncology: Head and Neck, MetasClinical trialsCROPharmaceutical IndustryICH-GCPCTMSoncologyGCPRecruitingClinical monitoringClinical DevelopmentDocuments règlementairesSecteur pharmaceutiqueEssais cliniques

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPsAct as the main line of communication between the sponsor and the investigatorAdminister supply requestAdministrative supportAnswer, transfer and handle incoming calls as needed.Archive documentationArchive study documentsArchive trial documentation and correspondence.Attend investigator meetingBuild trial master file (TMF)CoachCommunicate with investigatorCommunicate with sponsorCompile informationCoordinate with the ethics commiteeData entryDistribute study documentsDistribute trial suppliesEthics committee submissionsFollow up training programsFollow-up of external auditsGeneral office managementInteract with CROsInteract with ethics committeeInventory Management

Education

  • Master in Masters in Business Administration from IFAM in 2000

Training and Certification

  • GCP Refresher in 2015 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Native
    French
    Full Proficiency

Work Preferences

  • Positions I am interested in:
    Senior Clinical Trial Assistant
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Uccle, Belgium

Others

Driving License
  • Yes