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Summary

I have > 16 years of experience in clinical research.

  • Start-up, monitoring and management of multicenter clinical trials accross Europe.
  • Phase I-IV - expert in the national law (ie WMO) and regulations with respect to clinical trial submissions (ie CCMO guidelines).
  • Performing all submissions to Ethics Committees and Competent Authorities in NL
  • Managing the clinical team (CRAs and assistants) and maintain sponsor contact -developing monitoring tools, monitoring plan
  • Preparation and follow up of audits -performing QA checks -perform co-visits on site -training site staff (study specific and ICH-GCP)
  • Co-training for ICH-GCP course
  • Coaching/mentoring CRA's

Therapeutic areas with most expertise:

  • Hematology (Benign and Malign Hematology; FVII-, FVIII-, FIX-deficiencies, VWD, Multiple Myeloma, Lymphoma's),
  • CNS/Neurology (CIPD),
  • Ophthalmology (IOLs and Retinitis Pigmentosa),
  • Oncology (prostate carcinoma, ovarian cancer, SCLC and NSCLC Lung Cancer)
  • Infectious Disease/Inflammation (Chrohn's Diseas, Colitis Ulcerosa),
  • Orthopaedics/bone diseases.

Extended knowledge of clinical trial submissions in the Netherlands, Belgium and Germany for pharmaceutical and device applications. International experience in monitoring clinical trials in the Netherlands, United Kingdom, France, Germany, Sweden, Spain, Italy and Austria. Bachelor's Degree in Dutch law, extensive networker

Experiences

Current Experience

  • Senior Clinical Research Associate/Consultant
    Since October 2014
    Responsible for clinical studies in the Netherlands and Belgium

  • Senior Clinical Research Associate/Consultant
    Since September 2014
    management of a phase I/II trial in ovarian cancer in Belgium

  • Managing Director
    Since June 2009
    Staffing solutions for the bio-pharmaceutical and health care industry

Past Experience

  • Freelance Clinical Research Consultant
    January 2012 --- October 2015

    Monitor for several phase 1 studies. Monitor for a phase III Prostate cancer medication and device study

  • Freelance Clinical Research Consultant
    December 2010 --- September 2014
    Setting up Phase I-III clinical trials in the Netherlands including a phase I orphan drug Ophtalmology trial Phase III bladder cancer trial Phase III pediatric hematology trial Phase III trial in hematology in the Netherlands

  • Freelance Clinical Research Consultant
    July 2012 --- January 2014
    Freelance Monitor for a B-Cell Chronic Lymphocytic (B-CCL) Leukaemia study in Belgium. Freelance monitor for PTCL lymphoma trial in the Netherlands. Freelance monitor for a NSCLC trial in the Netherlands Freelance monitor for a Multiple Myeloma trial in the Netherlands

  • Freelance Clinical Research Consultant
    January 2011 --- July 2013
    Monitor for a phase I MTD oncology study in unresectable solid tumors Monitor for a phase III Prostate cancer medication and device study

  • Freelance Clinical Research Consultant
    March 2010 --- February 2012
    Performing Start-Up and for an Osteo-Arthritis trial

  • Freelance Clinical Research Consultant
    June 2010 --- November 2011
    Setting up, managing, monitoring 2 phase IV trials in Pulmonology and Neurology. Setting up and managing a pahse III virological trial

  • Freelance Clinical Operations Manager
    September 2009 --- April 2010
    Managing 6 studies in Hematology (ITP and MDS), Oncology (Sarcoma/soft tissue cancers and small cell lung cancer)

  • Clinical Research Specialist
    March 2006 --- June 2009
    Senior CRA: Clinical Research Associate on a phase III/IV AML trial. Performed Initiation visits. Senior CRA: Clinical Research Associate on a phase III/IV mantle cell lymphoma trial. Performed Initiation visits, full site management 10 sites (monitoring visits, internal study and financial management). Senior CRA: Clinical Research Associate on a phase III/IV multiple myeloma trial. Performed Initiation visits, full site management 20 sites (monitoring visits, internal study and financial management). Senior CRA: Clinical Research Associate on a phase III First in man drug eluting stent study. Performed full study management. Senior CRA: Clinical Research Associate on a phase III First in man drug eluting stent study. Performed full study management; protocol development, E-CRF development, set up of a clinical evaluation committee, set up of a data and safety monitoring board, monitor manual development, initiation and monitor visits. Senior CRA: Clinical Research Associate on a phase III Acute Coronary Syndrome trial. Performed full site management (monitoring visits, financial management, contract management), Close out visits Senior CRA: Clinical Research Associate on a phase III Advanced Follicular Lymphoma trial. Performed Initiation visits, full site management 6 sites (monitoring visits, financial management, contract management), Close out visits.

  • Medical Information Specialist
    May 2005 --- January 2006
    To give detailed information about a medical product(s) to health care professionals.

  • Clinical Research Associate (CRA)
    September 2002 --- May 2005
    Lead CRA: Clinical Research Associate on a phase III Over-Active Bladder (Urge Incontinence) extension trial. Performed selection of potential sites, pre-study visits, full site management 6 sites (monitoring visits, financial management, contract management). Lead CRA: Clinical Research Associate on a phase III Over-Active Bladder (Urge Incontinence) trial Performed selection of potential sites, pre-study visits, Initiation visits, full site management 6 sites (monitoring visits, financial management, contract management), Close out visits. CRA: Clinical Research Associate on a phase IV Crohn's registry. Performed selection of potential sites, pre-study visits, initiation visits, and interim monitoring visits full site management 11 sites. CRA: Clinical Research Associate on a phase III NSCLC Lung cancer trial. Performed selection of potential sites. CRA: Clinical Research Associate on a phase III NSCLC brain metastasis trial. Performed selection of potential sites, pre-study visits. CRA: Clinical Research Associate (supporting) on a phase III Prostate cancer study. Performed interim monitoring visits.

  • Clinical Research Associate (CRA)
    July 1999 --- August 2002
    Lead CRA: Clinical Research Associate on a phase III anti-fungal trial with patients suffering from systemic candida infections. Performed initiation visits, and interim monitoring visits full management over 21 sites. Lead CRA: Clinical Research Associate on a phase III anti-fungal trial with patients suffering from systemic aspergillus infections. Performed initiation visits, and interim monitoring visits full management over 21 sites. CRA: Clinical Research Associate on a phase III Alopecia study. Performed interim monitoring visits and close-out visits.

  • Klinische Forschungs Angestellter
    November 1998 --- July 1999
    CRA: Clinical Research Associate on a phase III Hypertension trial with patients suffering from diabetis and microaolbuminuria. Performed interim monitoring visits. CRA: Clinical Research Associate on a phase I anti-arrhytmica trial with healthy volunteers. Performed interim monitoring visits, and close out visits. CRA: Clinical Research Associate (supporting) on a phase II Anxiety trial with patients suffering from panic attacks. Performed support with site selection and trial set up.

Knowledge

LinkedIn Assessment :
HematologyClinical trialsoncologyCROClinical monitoringClinicalPhase ICancerClinical researchClinical trial managementGCPEDCCardiologyPharmacovigilanceICH-GCPInfectious diseasesMedical DevicesLife SciencesRegulatory affairsTherapeutic AreasSOPBiotechnologyImmunologyPharmaceuticalsClinical DevelopmentUrologyRegulatory submissionsCTMSPharmaceutical IndustryClinical operationsNeurologyPharmaceuticsBiopharmaceuticalsMedical writingMedicineProtocolDiabetesDrug DevelopmentVaccinesFDADermatologyRegulatory RequirementsHealth EconomicsClinical Research AssociatesClinical Data ManagementHealthcareCellmanagementpharmacologyHypertension

Education

  • Bachelor in Dutch Law from Leiden University in 2009
  • M.Sc. in Bio-Pharmaceutical Sciences from Leiden University in 1997
  • High school (VWO) in VWO Degree from Veurs College Leidschendam in 1991
  • Primary School in - from Biezenhof in 1984

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
Afrikaans
Elementary Proficiency
German
Professional Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    7 weeks
  • Positions I am interested in:
    Global Trial Manager Clinical Trial consultant Clinical Research Associate (CRA) Clinical Project Leader Clinical Project Manager (CPM)
  • Locations I am interested in:
    Augsburg, Germany Munich, Germany
  • Work From Home:
    Yes, 3 to 0 days per week
  • Work Regime:
    BrightOwl freelancer :    up to 20 hours per week (more negotiable) Hours per week
  • International:
    Yes

Area / Region

Munich, Germany

Others

Driving License
  • Yes