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I am a clinical development executive eager to learn and take on new challenges. I am forward-looking, focus on results and believe that success comes through hard work and persistence.

As a leader I want to shape my environment and help my team members to succeed by supporting and empowering them. As a professional I have a strong affiliation with e-clinical systems and related privacy, quality & regulatory aspects.

Experiences

Current Experience

  • Sr. Director, Head Data & Documents Operations

    Aachen, Germany
    Since February 2017
    Clinical Trial

    Provision of strategic leadership to a department consisting of 2 sub-teams (data management and documents management). Overall responsibilities include:

    • setting the scene for the collection and management of clinical trial data in compliance with GCP and applicable legislation;
    • driving new concepts for collection and management of the trial master file of clinical trials;
    • providing guidance towards strategy for current and new clinical trial technologies (EDC, ePRO, CTMS, mobile health, centralized data review);
    • managing the departmental budget as well as defining measures for improvement of services and operational efficiency.
    • Motivating, coaching and developing sub-team leads in their daily activities

    Additionally serve as serve as subject matter expert for data protection topics and support Quality Assurance in the execution of GCP audits of clinical trial technologies / systems.

Past Experience

  • Sr. Director, Head Data Management Aachen, Germany

    January 2014 --- January 2017
    Clinical Data Management

  • Operational Excellence Navigator & Stream Lead Aachen, Germany

    September 2012 --- January 2014
    Clinical Development

  • Project Manager Aachen, Germany

    November 2008 --- September 2012
    Clinical trials

  • eClinical Manager Aachen, Germany

    September 2010 --- August 2012
    Responsible for a mix of strategic and operative tasks related to the use of EDC and ePRO.

  • Clinical Data Manager Aachen, Germany

    August 2006 --- October 2008
    Clinical trials

  • Various Clinical Data Management Roles Brussels, Belgium

    November 1997 --- July 2006
    Clinical Data Management

Personality

Self Assessment :
AdaptabilityCritical thinkingFlexibilityIndependenceInterest in knowledgeOrganizationProblem solvingResult OrientedSelf-confidenceStrategic thinking

Knowledge

Self Assessment :
Change ManagementClinical Data Management (CDM)Clinical operationspeople managementProcess ManagementProject ManagementQuality ManagementSupplier ManagementLean Management

Skills and Expertise

Self Assessment :
Computerized System Validation (CSV)CTMSeCRFePRO / eCOAeTMFGCPGDPRIT StrategyIT System / Supplier AuditsMobile Health

Education

  • Further Education in Data Protection Officer from Syntra Limburg in 2018
  • Post Graduate in Relation & Communication Management from University Hasselt in 2017
  • Post-university Program in Project Management from EHSAL Management School in 2006
  • Masters - Industrial Engineer in Biochemistry from Katholieke Hogeschool Limburg in 1997

Training and Certification

  • Team Coaching (Syntra Limburg) in 2015 Training
  • Lean Management Training Program (McKinsey; INSEAD) in 2013 Training
  • Lean Six Sigma Business Green Belt (Smallpeice Enterprises) in 2011 Training
  • License to Lead (PROAKTIV) in 2011 Training
  • Quality Coordinator (Syntra Limburg) in 2011 Training
  • Project Management Professional (PMI) in 2007 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
German
Full Proficiency

Work Preferences

  • Positions I am interested in:
    Senior role in quality management Data Protection Officer / Expert Leadership role in (clinical) data sciences / data operations or (e)clinical systems Clinical Development Consultant (with focus on data sciences / data operations or (e)clinical systems)
  • Positions I am NOT interested in:
    Sales & Marketing
  • Locations I am interested in:
    Belgium Germany Netherlands
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Opglabbeek, Belgium

Others

Driving License
  • Yes

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