My Curiculum Vitae

Gerald Van RoeyGerald Van Roey MPhEd is the Managing Director of GVR Consultancy.

He has over 10 years of experience in Clinical Operations before switching his career into the training business in 2009. He worked as trainer and managing director for the ECCRT, European Centre for Clinical Research Training before starting his own company in 2015.

As a clinical monitor, he performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development. In his previous career he implemented different trial tools and mentored many junior CRAs. His extensive knowledge and background serves him as a manager and trainer for different courses. In his trainer function he has coached over 1.000 clinical research professionals and has delivered courses in 14 different countries.

As manager of the GVR Consultancy his focus lies on qualitative training, based on good course design and right methodology. Gerald sees himself as an ambitious person, who likes to achieve results in a way that satisfies every client. He's an active member of the board of “EFGCP” (European Forum for Good Clinical Practice) and is very much involved in the Education Working party of this organization. He has been asked to be a faculty- and programme committee member for various conferences and workshops of this organization.

Gerald is also the author of “Best Practice for Clinical Monitoring” (Pharmimage, ISBN: 978-3-86250-001-7) and published in various international magazines such as “International Clinical Trials”.

As Certified Myers-Briggs Type Indicator ® (MBTI) assessor, he wants to find the best possible links between personal preferences and the work environment, together with the individual. The knowledge gained can be implemented in various areas such as team communication, leadership, project management, change management, conflict handling and understanding one's preferred learning style.

Education

Oct 1995 - Sep 2000

Physical Education at Free University of Brussels (VUB), Brussels, Belgium
Final qualification: Master in Physical Education, cum distinctio

Languages

Dutch

Fluent (native speaker)

English

Fluent

French

Good

German

Basic

Professional Experience

Mar 2013 - Dec 2014

Manager Training Department at SynteractHCR, Brussels, Belgium

Mar 2013 - Dec 2014

Managing Director at ECCRT, Brussels, Belgium

Oct 2010 - Mar 2013

Training Manager at ECCRT, Brussels, Belgium

Apr 2009 - Oct 2010

Trainer at ECCRT, Brussels, Belgium

Aug 2007 - Apr 2009

Senior Clinical Research Associate at Ipsen NV, Merelbeke, Belgium

Jul 2004 - Jul 2007

Lead Clinical Research Associate / International Site Manager at Medifacts International, Home Based

Oct 2001 - Jul 2004

Senior Clinical Research Associate / International Clinical Study Manager at Msource Medical Development CRO
Outsourced to:

Apr 2004 - Jul 2004

Amgen, Brussels, Belgium

Nov 2002 - Mar 2004

Sanofi-Synthelabo, Brussels, Belgium

Oct 2001 - Nov 2002

Medtronic, Maastricht, The Netherlands

Oct 2000 - Sep 2001

Clinical Monitor at Byk Belga, Brussels, Belgium

Certification Licensure

2013

MBTI Step I Qualifying course, OPP Ltd, Diegem, Belgium

2013

Internal and External selling of Training, HRDacademy, Zwijnaarde, Belgium

2013

Line Management Course, SynteractHCR, Brussels, Belgium

2013

Clinical Project Management, ECCRT, Brussels, Belgium

2012

People Management Skills, ECCRT, Brussels, Belgium

2011

Working with CROs, ECCRT, Brussels, Belgium

2011

Data Safety Monitoring Committees in Clinical Trials, ECCRT, Brussels, Belgium

2010

Financieel Management voor de niet-financiele manager, Institute for Business Development, Gent, Belgium

2010

Clinical Project Management, ECCRT, Brussels, Belgium

2009

Train the trainer, Institute for Business Development, Gent, Belgium

2009

Medical Devices in Clinical Research, ECCRT, Brussels, Belgium

2009

GLP for GCP experts, GL expertise, Brussels, Belgium

2009

Clinical Research Training Course, National Institute of Health, UK (Computer based)

2009

Clinical Project Management, ECCRT, Brussels, Belgium

2009

EU CT Directive: Implementation in Belgium, ECCRT, Brussels, Belgium

2009

Clinical Research Training for junior CRAs , ECCRT, Brussels, Belgium

2009

Introduction to GCP Auditing in Clinical Research ECCRT, Brussels, Belgium

2009

Clinical Trial Inspections: Preparing for a Good Outcome ECCRT, Brussels, Belgium

2009

Comparing US Regulations with ICH GCP Regulations ECCRT, Brussels, Belgium

2009

HCR Intro Course, ECCRT, Brussels, Belgium

Clinical Trial Experience

Phase II, Phase III and Phase IV trials in Intensive Care, Stop Smoking, Metabolism, Gastro-Enterology, Cardiac Rythm Management and others. Both CRO and Company based for Pharmaceutical, Medical Device as Biotech companies.

Memberships

  • The European Forum for Good Clinical Practice (EFGCP)
    • Board Member (since 2012)
    • Member of the Working Party on Education
    • Vice Chair (since 2014)

Professional Training (last 5 years)

2014

ACRP Belgium Scientific meeting: “Introduction to the New European Regulation on Clinical Trials on Medicinal Products for Human Use”, Mechelen, Belgium

2013

16Th European Conference of ACRP: “Late breaking Clinical Trial News 2012”, Brussels, Belgium

2013

EFGCP Multi-Stakeholder Roundtable Meeting on “Sharing Clinical Trial Data in the Interest of Patients and Research”, Brussels, Belgium

2013

EFGCP Workshop on A Practical Approach to Risk-Based Monitoring, London, UK

2013

ACRP Belgium Scientific meeting: “Remote Monitoring”, Mechelen, Belgium

2013

ACRP Belgium Scientific meeting: “Insurance and Clinical Trials”, Brussels, Belgium

2013

EFGCP Annual Conference 2013, Virtual Future: The ethical dimensions of emerging technologies in clinical trials and research, Brussels, Belgium

2012

ACRP.be 15th National Conference, “Late breaking Clinical Trial News 2012”, Brussels, Belgium

2012

ACRP Belgium Scientific meeting: “Informed Consent”, Mechelen, Belgium

2012

ACRP Belgium Scientific meeting: “Quality control: How central monitoring identifies sites at risk, and what investigator sites can do to enhance quality?”, Mechelen, Belgium

2012

EORTC 50 years of Progress against Cancer (9 ECMECs)

2012

EFGCP Annual Conference 2012, Informed Consent - How less could be more: Effecting a paradigm shift so we do inform participants, Brussels, Belgium

2011

ACRP Belgium Scientific meeting: “Risk Based Approaches to Trial Monitoring”, Mechelen, Belgium

2011

EFGCP Annual Conference 2012, Informed Consent - How Less could be More: Effecting a paradigm shift so we do inform participants, Brussels, Belgium

2011

ACRP Belgium Scientific meeting: “Social Media: Share of shiver?”, Mechelen, Belgium

2011

ACRP Belgium Scientific meeting: “Principal Investigator Oversight”, Vilvoorde, Belgium

2011

EFGCP Annual Conference 2011, Certified GCP Training Needs Solutions, Budapest, Hungary

2010

ACRP.be 13th National Conference, “Late breaking Clinical Trial News 2010”, Brussels, Belgium

Publications & Presentations

2014

Faculty member & Chairperson: EFGCP Workshop on Striving for Professionalism in IITs, Brussels, Belgium

2013

Article: “Train to Gain” in International Clinical Trials, August 2013, p42

2013

Rapporteur: Workshop on A Practical Approach to Risk-Based Monitoring of  EFGCP 2013, London, United Kingdom

2013

Rapporteur: Workshop: Preparing for the future: training needs analysis: researchers and research ethics committees and reviewers of  EFGCP Annual Conference 2013, Brussels, Belgium

2011

Publication: Book: Van Roey G. “Best Practice for … Clinical Monitoring”. PharmImage GmbH, ISBN 978-3-86250-001-7

2011

Article: “Education, education, education” in International Clinical Trials, May 2011, p80-82

2010

Presentation: “Training as the engine of continuous quality” Harrison Clinical Research Benelux Event - Brussels, Belgium 06/05/2010

2010

Presentation: “Clinical Research with Medical Devices” 13th National Conference of The Belgian Association of Clinical Research professionals (ACRP.be) - Brussels 22/10/2010

2010

Presentation: “Efficient training results in quality trials “ Seminar “Improving efficiency in clinical trials” by Leuven.Inc and Flanders Smart Hub - Leuven, Belgium 10/12/2010