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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 / science)" >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 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

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

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