• rue Thomas Edison, 1

      1445 Luxembourg

      Luxembourg

    • 131
      Citations
    20142024

    Research activity per year

    Personal profile

    Biosketch

    Biography

    Master diploma in Cell Biology and Physiology from the University of Versailles St Quentin en Yvelines (UVSQ), France, Diploma in ‘Clinical Data Management’ from the Institute Léonard de Vinci – La Defense, Paris.

    Worked as a clinical data manager in the cancer institute ‘Gustave Roussy’ in Villejuif, France, from 2008-2016, and since 2016 working in the Luxembourg Institute of Health.

    Data Management experiences

    Redaction of data management plans according to GCDMP edited by SCDM-USA, DCC-UK, H2020-France.

    Design of CRFs according to protocols, and development of EDC using softwares Ennov Clinical, Redcap InferMed MACRO and OpenClinica. Cross-disciplinary approval and testings by end-users and validations. Production of annotated CRFs and associated data dictionaries, including: dataset names, field names, formats, units, logic edit checks, conditional skipping and logic derivation tests. Writing up of guidance documents: “Manual for Keyboarders”, “Userguide for EDC”.

    Versioning of the EDCs according to internal SOPs, documentation of changes, testings in draft mode, communication to relevant staff.

    Users trainings for data entry, users support, management of personal roles within the study, and attribution of individual access to the EDC. Double data entry comparisons.

    Tracking of late CRF pages (paper CRF/eCRF) and actions taken to optimise the flow.

    Redaction of edit checks validation document per study, programming of edit checks appearing during data entry, as well as post data entry. Management of the queries flow: raising queries, resolution tracking and quality documentation (periodical study metrics). Management of Source Data Verification online processing in coordination with CRAs.

    Management of data sharing plateforms: secure data transfers, data mapping, data curation, automatic data imports.

    Data reconciliation (e.g. with pharmacovigilance department), data coding MedDRA/WHODRUG,/SDTM Terminology). Management of eCRF signature and CRF lockings after completion and queries resolution, according to internal SOP.

    Quality experiences

    Update of internal SOPs regarding all data management processes (ISO 9001 2015 certification).

    In charge of evaluation and comparison of fonctionalities of several EDC under licence.

    Participation in the writing up of “Standardized CRF Template in oncology”, Institute Gustave Roussy.

    Training in CDISC-SDTM, participation in GUF-CDISC, group Aca-DM in France, implementation of CDISC standards and Controlled Terminology within both institutions (Gustave Roussy and LIH).

    Auditor experiences

    ECRIN, Auditor - expertise in domains Clinical Data Management:

    -Audit Data Center ZKS Koln, Germany, (November 2019)

    -Audit Data Center IBA Brno, Czech Republic, (October 2023)

    Teaching experiences

    LIH, Strassen, Luxembourg: “Clinical data management training” in the scope of WHO program Capacity Building program (since 2016), including “Data Manager roles and responsibilities in GCP”.

    University of Luxembourg: “How to Develop a Data Management and Sharing Plan”, training workshop (2018)

    Data management training supervisor and modules development for “Renforcement de la gestion des données sanitaires pour soutenir la recherche en Afrique Subsaharienne” in the scope of WHO program Capacity Building program (since 2017)

    ECRIN:“Advanced Data Management courses”, “DM Systems - Developing Study database” (May 2023)

    Actually in charge of Data Management of the following projects:

    Predi-Covid, DigiCog, Crypto-HIV, Clinnova-RD

    Education/Academic qualification

    Master, Master of Science, Cell Biology and Physiology, Université de Versailles Saint-Quentin-en-Yvelines

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