Assistant essais cliniques
Updated: May 03, 2024 08:26 PM GMT
NOVADIP Biosciences S.A.
Mont-Saint-GuibertYour responsibilities
Primary Role
Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities.
Nature and scope of responsibilities
1.Trial Master File (TMF) management from study start-up to close-out, ensuring all essential documents and relevant correspondence are filled in a timely manner.
• Development of TMF Plan in collaboration with Clinical Project Manager (CPM). o Set-up, maintenance, close-out and archiving of Sponsor TMF.
• Ongoing filing of documents and maintenance of related TMF inventory
• Assist the CPM with periodic reviews of the Sponsor TMF, including outsourced sections, as needed.
• Preparation and distribution of the Investigator Site Files. o Tracking of filed documents in Sponsor TMF and Investigators Site Files (ISF), and proactive alerting the CPM or CRA, as appropriate, on missing documents.
2. Administrative... More Detail
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