clinical trials electronix test file administrator - Lodi (LO) - beBeeElectronicTrialMasterFile

    beBeeElectronicTrialMasterFile
    beBeeElectronicTrialMasterFile Lodi (LO)

    1 settimana fa

    Titolo del lavoro: eTMF Specialist

    Descrizione

    Job Title

    A Global Electronic Trial Master File Specialist is required to oversee the global eTMF operations for GRD R&D. The ideal candidate will have a strong understanding of ICH/GCP guidelines and applicable regulations.


    The specialist will be responsible for creation, revision, and maintenance of all eTMF associated procedures, ensuring they are up-to-date and compliant with regulatory requirements. This role involves leadership responsibilities to ensure quality KPIs are met and eTMFs are inspection ready at all times.


    Key Responsibilities:





    The position also involves providing support during internal/external audits or inspections on document retrieval; communication regarding team processes; resolving identified issues directly with agency inspectors (FDA) / auditors along with other stakeholders where possible.


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