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Summary

Results oriented people leader with a systematic approach to problem solving and focus on implementation of long term solutions. Customer oriented and strong believer in building success through partnerships.

Experiences

Current Experience

  • Managing Partner / Consultant
    Since November 2016
    Provide support in the following areas : • Strategy development • Clinical Data Submissions • Outsourcing • Clinical Data Management • Process Design and Optimization • Change Management

Past Experience

  • VP, Integrated Data Analytics & Reporting, Janssen
    July 2015 --- October 2016
    Accountable for setting the strategy and operational execution of the data delivery and analysis (DDA), risk management – central monitoring, regulatory medical writing capabilities related to functional outsourcing, external and internal clinical trial data flows, data transparency and submissions.

  • VP, Global Head, Integrated Data Services, Janssen
    March 2014 --- June 2015
    Accountable for setting the strategy and operational execution of data management in line with R&D priorities and Therapeutic Area Objectives

  • Sr. Director, Data Management Operations Head, Janssen
    August 2011 --- February 2014
    Accountable for setting the strategy and operational execution of data management operations in line with R&D priorities and Therapeutic Area Objectives

  • Director, Data Management Head Infectious Diseases, Janssen
    June 2009 --- July 2011
    Manage Data management team through outsourcing and off-shoring, responsible for integration of Tibotec data management group in Janssen Pharmaceuticals

  • Ass. Director, Data Management Head Virology, Tibotec
    November 2007 --- May 2009
    Accountable for successful delivery of all Therapeutic Area deliverables on time, within budget and meeting quality requirements for all DM activities in Early Development, Full Development and post-marketing studies

  • Lead Data Manager, Virology, Tibotec
    February 2003 --- October 2007
    Co-ordination of all data management activities for HIV compounds. Active member of clinical team, responsible for follow up of regulatory guidelines, technological advances and industry standards. Member of PRC, lab and J&J standards team

  • Project Manager
    October 2002 --- February 2003
    Planning and set-up of laboratory requirements for clinical trials, co-ordination of logistics and resupplies. Main client contact for all departments in the laboratory

  • Sr. Data Coordinator
    April 2002 --- October 2002
    Development of proposals, main contact for all project management responsibilities related to data management. Line manager for clinical data coordinators

  • Data Manager
    February 1999 --- March 2002
    Team lead and primary client contact for all trial related data management activities

  • researcher
    January 1998 --- January 1999
    In vitro and In vivo analysis of anti-fibrogenic effects of histone deacetylase inhibitors

  • IT Analyst
    October 1996 --- October 1997
    Impact analysis for euro conversion and Y2K on general ledger

  • researcher
    July 1995 --- October 1995
    Effect of weeds and cover crops on the survival of banana nematodes in Honduras

Knowledge

LinkedIn Assessment :
Clinical DevelopmentEDCClinical Data ManagementCROData ManagementGCPDrug DevelopmentPharmaceutical IndustryCTMSICH-GCPSOP21 CFR Part 11Regulatory submissionsClinical monitoringSOPoncologyGood Clinical Practice (GCP)Infectious diseasesCRO managementClinical researchStandard Operating Procedure (SOP)Electronic Data Capture (EDC) U.S. Title 21 CFR Part 11 RegulationClinical trials

Education

  • Master in Medical and Pharmaceutical Research - Year 1 in from Vrije Universiteit Brussel in 1998
  • Master of Science in Bio-engineering in land and forestry management and tropical agriculture from KU Leuven in 1996
  • in from Sint-Lutgardis, Antwerpen in 1991
  • GCSE in from United World College of South East Asia in 1989

Training and Certification

  • CDISC - SDTM in 2003 Certification
  • PMP Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Native
Dutch
Native
French
Professional Proficiency

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    30 Hours per week :    60 Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes