MEDIDATA SUPPORT SERVICES (Freelance)

Nous recherchons un(e) Consultant(e) Administratration de Médata (Freelance) autonome pour poursuivre la recherche et la production de nanoparticules qui pourront aider des millions de patients à travers le monde. Notre recherche innovante est en plein développement et offre une expérience unique.

Depuis notre création, notre équipe s'est engagée dans la recherche et le développement de méthodes disruptives en nanomédecine qui pourraient révolutionner la manière dont de nombreux cancers sont traités.

Nanobiotix conçoit et fabrique des nanoparticules qui améliorent en toute sécurité l'efficacité de la radiothérapie dans le traitement du cancer. Nous croyons que la radiothérapie combinée avec le NBTXR3 peut devenir une nouvelle norme de soins dans le traitement du cancer.

The Medidata Administrator is responsible for the management, maintenance, and improvement of the Clinical Trial Management System (CTMS).

This individual will work directly with the Clinical Study Teams, leading the operational management of the CTMS and the Trial Master File (TMF). A focus on inspection readiness is critical.

As a CTMS Subject Matter Expert (SME):

Manage all upgrades and perform all System Administration responsibilities, including User Account Management, maintenance of system libraries and periodically system audits.

Act as a liaison between end-user groups using the system and the system developer.

Reporting and Analytics: Communicate and escalate reports updates/issues to stakeholders regularly.

Lead the development of the CTMS User Training Plan and execute the plan after implementation (internal and external).

Collaborate with vendor on the ongoing CTMS system issues, upgrades, and maintenance

TMF Management:

Create and manage study specific TMFs

Independent preparation, review, collection, and approval of documents required for study start up in agreed upon timelines and in accordance with ICH, GCP, and all applicable regulations, laws and other

TMF documentation review and management as needed.

Monitor completeness and quality of the TMF (start up to archival), including elements outsourced to CRO and provide status updates to Clinical Study Teams

Medidata eTMF (2 studies) & CTMS ( 1 study 10 sites )

• Expertise in utilizing CTMS and TMF systems, Medidata experience highly desirable.
• Advanced working knowledge of DIA Reference Model TMF structure (preferably Version 3. 0) Thorough understanding of clinical trial operations, ICH/GCP guidelines and FDA regulations
• General knowledge of medical terminology
• Communication with end-users
• Preparation and updates of working instructions and training material
• End user training
• Potential data migrations
• Systems updates
• UAT tests
• Related SOP Maintenance
• ETMF & CTMS Change control management related to new versions of Medidata,
• Internal documentation and archiving

• Medidata reports production for COLs ,

• Protocol deviations, etc
• lists of monitoring visits,
• ICFs reports,

• follow up letters

• E TMF specifics: creation of new documents in the system and change the document types
• Services are Clin Ops related ( CTMS / ETMF ) but IT & system expertise support could be needed in this transition phase.

Mission duration : 1 year, 2 days per week