BrightOwl Loader Loading


Current Experience

  • Project Clinical Data Manager
    Since January 2013
    Support the enhancement of Clinical Data Management processes and standards - Analysis of Clinical Data Management processes and standards - Creation and maintenance of Standard Data Validation Plan - Support the implementation of the protocol deviations process Support the introduction and implementation of the Lean Management methodology - Trained as dedicated expert to act as internal consultant and to drive the change by bringing the Lean Management methodology and continuous improvement Change Management at Grünenthal - Assigned as change agent to facilitate the major changes at Grünenthal by ensuring good communication throughout the change process Management of Clinical Data Management activities at compound level - Provide input to Clinical Core Team where Clinical Data Management expertise is required - Provide functional lead to Clinical Data Managers responsible for trials within the assigned compounds - Ensure consistent Clinical Data Management services Management and supervision of Data Management CRO for outsourced Clinical Data Management services regarding timelines, operational aspects, status, budget and quality, … at trial level: - Prepare, conduct and close Data Management activities - Ensure that all functional activities are performed to meet the defined timelines, budget and quality specifications - Be responsible for the interface with different Grünenthal departments (e.g. Science, Operations, Drug Safety) - Provide input into the selection, qualification and contract negotiations of Data Management CROs and ePRO providers

Past Experience

  • Global Data Manager at Tibotec
    April 2009 --- December 2012
    • Coordination of the various inputs and contributions into the generation and review of clinical data management documents (Data Management Plan, Annotated CRF, Database Specifications, Data Review Guidelines, Data Transfer Agreements, Data Flow Diagram, Safety Monitoring Plan, Trial Plan, etc.) and addenda or amendments thereof for consistency with company procedures and templates, as well as other clinical data management documents, in particular pertaining to regulatory submissions (SDTM data) ; • Attendance of protocol review meetings, kick-off meetings with EDC vendor, eCRF screen and edit checks review meetings, clinical trials meetings, clinical team meetings, Investigator and monitor meetings • Overseeing the allocation of clinical data management document generation to external Parties (this includes Data Management Providers and Ancillary Data Providers) for assigned virology compounds ; • Close follow-up of timelines with external Parties for assigned studies ; • Close follow-up of Data Management activities by external Parties and participation in problem solving of chronic issues with external Parties ; • QC checks on SDTM data for assigned virology studies • Review of budgets with external parties for Data Management activities ; • Actively participate in CDISC implementation ; • Data Management point of contact concerning Virus Resistance Data and Pharmacogenomic Data • Coordination of eClinical system Integrations of EDC, IWRS and CTMS

  • Clinical Data Coordinator at UCB Pharma
    April 2006 --- March 2009
    • Review and approval of data management documents provided by the CRO (Data Entry Guidelines, Data Cleaning Plan, Data Management Plan, Data Management Report, Lab Data Transfer Specifications, Database Design Reports, Self Evident Corrections, Quality Control Plan, … ) • Review of Protocol, Statistical Analysis Plan, Budget (update), Task Allocation Matrix, Contract (amendment), … • Creation of CRF Tracking and Scanning Guidelines and CRF Printing Requirements • Ongoing and final QC of the SAS databases provided by the CRO • Design of CRF according to the Protocol utilizing Data Standards and documenting deviations • Annotation of CRF according to UCB Data Standards • Review of query management by the CRO • Answering to questions from CROs about UCB guidelines and any study specific problems • Supervision of the CRO Data Management activities and follow-up on the compliance with the agreed timelines • Ensuring that all sub-contracted activities are compliant with applicable regulations (e.g.: ICH-GCP Guidelines) • The QC and filing of the (CRO) Data Management documentation before transfer to the Trial Master File • Attending (bi-)weekly meetings with the CRO, monthly meetings with the trial teams, pre-analysis meetings, bid defence meetings, F2F meetings, … • Main point of contact for all GMA related Data Management aspects (from Sep2008)

  • Clinical Data Coordinator
    June 2005 --- March 2006
    Data entry; Data review; e-CRF Design; Develop Data Entry Guidelines and Data Cleaning Plan; Program and validate electronic checks; Quality control of Data Entry Applications; Filing


LinkedIn Assessment :
Data ManagementCDISCCRF designEDCCROICH-GCPSASProtocolClinical Data ManagementGCPClinical trials21 CFR Part 11CTMSSAS programmingDatabase DesignClinical researchSDTM


  • Sports Management in from VLEKHO in 2004
  • Master's degree in Biomedical Sciences, General from Vrije Universiteit Brussel in 2003

Area / Region

Aken, Duitsland


Driving License
  • No