Global Study Manager

Excelya>Full-time>Global Study Manager

Job description

Established in 2014, Excelya is a ‘people centered’ contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop-shop service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

Mission :

  • Define scope of work for outsourcing of clinical study activities to pre-selected CROs
  • Coordination of Core/Extended study team deliverables (meeting, action/issue Decision Log)
  • Study timelines maintenance, consistency and execution, retro planning for key milestones
  • Study reporting, global communication, Lessons Learnt
  • Key Study documents review (e.g: study outline, study protocol and clinical study report)
  • Study plans (e.g. (centralized) Monitoring Plan): maintenance and FU
  • Study Risk identification/mitigation (e.g. study risk Management Plan)
  • Clinical Trial Management System (CTMS): compliance
  • Oversight of (e)TMF maintenance
  • Study budget: Study budget & forecast follow-up (tracker)
  • Quality: Audit/inspections preparation, FU and closure, QC (in process control), CAPA approval for critical deviations
  • Service Provider: Review of metrics, status, oversight plan approval and other key plan approval (e.g. project/communication plan), Change Order validation,
  • Data management: Coordination of transfer of eTMF into sponsor TMF repository, oversight of data cleaning and clinical data base lock activities on CRO side, over sight of centralized monitoring activities conducted by the CRO, critical data identification.
  • Based in Montpellier.

Profile:

  • Rigorous, organised and excellent interpersonal skills.
  • Higher education (ideally 5 years of higher education).
  • You have experience in clinical research
  • Fluency in written and spoken English required

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