Marc Laberny

Angestellt, Clinical Data Standards Governance Lead, CSL Behring

Fähigkeiten und Kenntnisse

Datenmanagement
Klinische Daten
Logistik
ERP
Personalmanagement
Abteilungsleitung
Data Quality
Personalführung
Personalplanung
Changemanagement
Computer System Validation
GCP
GMP
Data governance
Computer Systems Validation

Werdegang

Berufserfahrung von Marc Laberny

  • Bis heute 2 Jahre, seit Mai 2024

    Clinical Data Standards Governance Lead

    CSL Behring

    - Served as Chairman of the Change Control Committee within the Clinical Data Standards domain, overseeing strategic decisions on the lifecycle management of standards - Led efforts to streamline Data Management and Clinical Programming processes, helping shape procedural standards and drive ongoing improvements

  • 2 Jahre und 5 Monate, Okt. 2021 - Feb. 2024

    Head of Clinical Standards

    Parexel

    - Led the development, management, and governance of clinical data standards in alignment with CDISC (CDASH, SDTM) requirements, ensuring consistency across studies and regulatory compliance - Collaborated with cross-functional teams and 3rd party vendors (Palantir, Precision Digital Health, Collibra), to design and implement platforms enabling Real World Data (EHR, clinical registries) integration. Spearheaded the transformation of heterogeneous data sources into a unified common data model

  • 4 Jahre und 11 Monate, Nov. 2016 - Sep. 2021

    Associate Director, Clinical Database Programming

    Parexel

    - Managed and mentored a team of 16 clinical programmers (working on platforms including Medidata Rave, Veeva EDC and elluminate) across the EMEA region - Oversaw the validation lifecycle for multiple EDC and DCT platforms (Advarra Forte EDC, Thread), maintaining a state of continuous regulatory compliance - Championed clinical data technology activities supporting the execution of innovative Real World Evidence studies, including hybrid designs and synthetic control arms

  • 4 Jahre und 3 Monate, Aug. 2012 - Okt. 2016

    Senior Manager, Clinical Database Programming

    Parexel

    - Managed and mentored a team of up to 25 professionals, ensuring structured onboarding, continuous training, and career development. Oversaw the execution and productivity of EDC (DataLabs, Medidata Rave, Inform) and statistical programming activities (SDTM), maintaining high standards of data quality, compliance, and delivery timelines across clinical projects - Served as system owner for the DataLabs EDC platform, ensuring the system remained in a validated state in line with regulatory requirements

Sprachen

  • Deutsch

    C1 (Fließend)

  • Französisch

    C2 (Verhandlungssicher / Muttersprachlich)

  • Englisch

    C1 (Fließend)

  • Spanisch

    B1-B2 (Gute Kenntnisse)

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