BrightOwl Loader Loading

Summary

Freelance Clinical Research Associate / Project Manager specialized in supporting clinical trials in different areas for phase I up to IV clinical trials according to ICH-GCP standards. I am highly experienced with the complete trial cycle, from feasibility through submissions initiation, monitoring and close-out. Over 11 years of experience in clinical trials in both pharmaceutical and medical device industries: - 5 years of monitoring phase II-III trials in oncolology trials. - International CRA monitoring in Belgium, the Netherlands, Germany and Croatia for a biotech company (Orthopaedics). - Coordinating CRA responsible for CRA training, presentations and organization of Investigator Meetings and Project Management tasks including CRF / Protocol design, CSR review, etc. - Thorough experience in managing the imaging logistics (collection, validation, storage and analysis of MRI, CT, Rx, etc.) during clinical trials. - Experience with internal company audits, FDA inspections and EMEA inspections. - Several trials in various therapeutic areas including Oncology, Nephrology (Hemodialysis), Renal and LiverTransplant, Rheumatology, Diabetes, gastroenterology , Dermatology, Neurology and Phase 1 first in human . Specialismen: - Oncology (4+ years) - Orthopaedics (2,5 years) - Rheumatology (2+ years) - Renal and LiverTransplant (1,5 years) - Nephrology (2 years) - Phase 1 (first in human) - Start-up expert: Feasibilities, Pre-study visits, Submissions & SIVs for several projects.

Experiences

Current Experience

  • Freelance CRA / Project Manager
    Since May 2010
    Past projects: CRA for Nephrology and Transplantation trials at Novartis Belgium, Start up & submission Oncology Trials Novartis for Clinx AZ. Current Projects: Oncology trial for Roche, Case Manager for ImagineSCT, Neurology & Rheumatology trials for Novartis, Phase 1 trial for Novartis

Past Experience

  • Clinical Research Associate (outsourced Novartis)
    January 2009 --- May 2010
    Clinical Research Associate

  • Clinical Research Associate (CRA)
    January 2006 --- December 2008
    Clinical Research Associate

  • Clinical Research Associate (outsourced)
    January 2004 --- February 2006
    Clinical Research Associate

  • Clinical Trial Assistant (outsourced)
    May 2003 --- January 2004
    Clinical Trial Assistant

Knowledge

LinkedIn Assessment :
Start-upsClinical trialsFeasibilitiesGCPClinical researchCROElectronic Data Capture (EDC) Clinical monitoringClinical DevelopmentCTMSPharmaceutical IndustryICH-GCPoncologyMedical DevicesRegulatory affairsClinical Data Management (CDM)Regulatory submissionsBiotechnology

Education

  • GGS in Physiotherapy of Sports from KU Leuven in 2001
  • Master in Motor Rehabilitation and Physiotherapy from KU Leuven in 2000

Area / Region

Belgium (Leuven)

Others

Driving License
  • Yes