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.
Sr. Director, Head Data & Documents OperationsAachen, Germany
Since February 2017
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.
Sr. Director, Head Data Management Aachen, GermanyJanuary 2014 --- January 2017
Clinical Data Management
Operational Excellence Navigator & Stream Lead Aachen, GermanySeptember 2012 --- January 2014
Project Manager Aachen, GermanyNovember 2008 --- September 2012
eClinical Manager Aachen, GermanySeptember 2010 --- August 2012
Responsible for a mix of strategic and operative tasks related to the use of EDC and ePRO.
Clinical Data Manager Aachen, GermanyAugust 2006 --- October 2008
Various Clinical Data Management Roles Brussels, BelgiumNovember 1997 --- July 2006
Clinical Data Management
AdaptabilityCritical thinkingFlexibilityIndependenceInterest in knowledgeOrganizationProblem solvingResult OrientedSelf-confidenceStrategic thinking
Change ManagementClinical Data Management (CDM)Clinical operationspeople managementProcess ManagementProject ManagementQuality ManagementSupplier ManagementLean Management
Skills and Expertise
Computerized System Validation (CSV)CTMSeCRFePRO / eCOAeTMFGCPGDPRIT StrategyIT System / Supplier AuditsMobile Health
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