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Summary

G. De Bock has > 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) -speaker on Investigator's Meetings -co-training for ICH-GCP course -coaching/mentoring CRA's -representative for NL for the global COM Network for Amgen B.V. -representative (occasionally) for Amgen B.V. at Nefarma Meetings -therapeutic area with most expertise: Infectious Disease/Inflammation (Chrohn's Diseas, Colitis Ulcerosa, aBSSSI, CABP), Nephrology (SHPT), CNS/Neurology and Orthopaedics/bone diseases.

Experiences

Current Experience

  • Clinical Trial Manager
    Since July 2014
    Primary responsibilities include, but are not limited to: •Study Planning: ensure detailed study schedule, budget and timelines are created that are in line with estimates. Participation in protocol preparation. • Study execution: plan, lead and coordinate all assigned activities of study execution including site selection, regulatory document collection, site initiation, site monitoring, data management, coordination of external parties such as steering committees, and site close out in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. • Study team leadership/management: Act as the primary point of contact for the study and manage day-to-day communication and activities of the Study team. This includes internal and external team members, vendors and corporate partners. As needed, solve or lead the study team in developing solutions to day-to day study issues. Drive all study team members to effectively communicate and coordinate activities. Create the agenda for, lead and drive the study team meetings to run efficiently and effectively. • CRO/ Vendor Management: participate with vendor selection, assist in the development of the scope of work, and ensure effective tracking of Study progress, data quality and vendor performance, based on pre-specified metrics. Work with study team members in the selection and supervision of vendors (such as CROs and central laboratories, etc).

Past Experience

  • Clinical Operations Manager
    July 2009 --- June 2014
    • Managing feasibility processes • Plans, manages and executes Amgen sponsored studies • Actively contributes to results oriented department goals • Identifies opportunities and best practice with partners • Supervising CRO activity • Ensuring adequate decisions on site selections • Approval of monitoring visit reports and Site Initiation Packages • Writing and approving Informed Consent Forms • Management of local study budget • Issue escalation from findings from sites • Representative for NL for the global COM Network for Amgen • Representative (occasionally) for Amgen B.V. at Nefarma

  • Project Leader
    July 2007 --- June 2009
    Line management responsibilities: administrative responsible for 5-7 CRAs and assisrants; coaching, mentoring, recourcing, bi-yearly appraisals. Project management responsibilities for national and international clinical trials.

  • Senior Clinical Research Associate
    October 2004 --- July 2007
    Project management (national and in EU) for clinical trials. Founder of a study Start Up Group and responsible for (coordination of) all submissions of clinical trial packages to the Competent Authorities and Judging Ethical Committees in NL.

  • Senior Clinical Research Associate
    July 2003 --- July 2007
    Monitoring several sites in Belgium and The Netherlands for phase II and III clinical trials.

  • Clinical Lead
    January 2004 --- January 2005
    Project Management Clinical Trials in EU with financial responsibility for phase III trials. Co-trainer for ICH-GCP course.

  • Primary CRA
    July 2003 --- January 2004
    Project Management of most EU countries for a large phase III clinical trial (CNS, stroke) with financial responsibility.

  • Clinical Research Associate (CRA)
    September 1997 --- July 2003
    Monitoring several sites in Belgium and The Netherlands for phase II and III clinical trials.

  • Research Technician
    May 1995 --- June 1997
    Reseach project: functionality of MDR1A P-glycoprotein at the blood-brain barrier".

  • Research Technician
    February 1994 --- December 1994
    Study to the role of the 5-HT1A –receptor in the regulation of the extra cellular serotonin level in the median raphe: an in vivo micro dialysis study in freely moving guinea pigs).

Knowledge

LinkedIn Assessment :
ICH-GCPClinical researchPharmaceutical IndustryClinical trialsClinical DevelopmentClinical monitoringBiotechnologyBiopharmaceuticalsNephrologyInflammationCNS disordersSOPphase I-IVEndocrinologypediatric trialsGynaecologyGCP

Education

  • Bachelor of Science (B.ASc.; University of Applied Science). in Zoology (zoological engineer; use of laboratory animals for in vivo scientific research) from Hogeschool Utrecht in 1995
  • Radiation Protection level 5B (Stralingshygiene, niveau 5B) in Course for the use of radioactive compounds in scientific research from Technische Universiteit Delft in 1993
  • Course: ex. Art. 9: qualification for the use of animals in scientific research in from Universiteit Utrecht in 1992

Area / Region

Amersfoort, Nederland

Others

Driving License
  • Yes