Société : Fortrea Lieu : Brussels Brussels Site source : Talent BE
The ClinTrialsAdmin/Snr ClinTrialsAdmin is responsible for providing support to the clinical study team for the set up and administration of electronic Trial Master File (eTMF) ensuring adherence to protocol, Good Clinical Practices (GCP) guidelines and company Corporate and Local Standard Operating Procedures (SOPs).The ClinTrialsAdmin/Snr ClinTrialsAdmin is part of the study team and will collaborate with the people involved in the conduct of the registries from the start-up, up to the closing and archiving activities.
ClinTrialsAdmin/Snr ClinTrialsAdmin will interact with the clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site’s staff, when applicable, to ensure that all the administrative tasks are completed in a timely manner.Essential duties:
TMFResponsible for the eTMF set up system for the Rare Disease RegistriesSet-up, manage and keep the local trial master files (paper & electronic) up-to-date in association with the CPL and CRAs in accordance with the applicable SOPs for filing of trial documents in such a way that any relevant information can be presented promptly during audits and inspections.Manage the upload of documents for all existing and new sites and ensure a primary Quality control (QC).Ensure correct and proper classification of the documents in the eTMF systemControl study team compliance to ensure TMF inspection-readiness at any timeTo ensure completion and tracking of the volume of documents uploaded in the systemResponsible for TMF archiving process -Preparation of archiving, collection, reconciliation and filing of relevant documents.Focus on Customer Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsorsEffective relationship management, sites, and study teams, participate to team spirit and motivationPursue Scientific and Process Excellence Good attention to detailMethodical approach to work and prioritization of tasksUnderstanding of the principles of ICH-GCP and applicable local regulatory requirementsBe comfortable with emerging technologies, mobility applicationsWork with Others Good organizational skillsThe ability to communicate effectively in English.Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
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