TMF Management Specialist

il y a 2 semaines


Lyon, Auvergne-Rhône-Alpes, France Excelya Temps plein
Job Title: TMF Management Specialist

Excelya, a leading Contract Research Organization (CRO), is seeking a highly skilled TMF Management Specialist to play a crucial role in ensuring the smooth execution of clinical trials.

About Excelya

Founded in 2014, Excelya is a young and ambitious health company on the path to becoming the clinical research leader in Europe. Our unique one-stop provider service model allows our team members to evolve through a diverse array of projects, collaborating with preeminent experts to advance scientific, managerial, and human knowledge.

Key Responsibilities
  • TMF Set-up and Closure: Ensure timely and accurate set-up and closure of Trial Master Files (TMFs) for assigned clinical trials.
  • TMF Management Activities Oversight: Monitor and oversee TMF management activities to ensure compliance with regulatory requirements and industry standards.
  • TMF Plans Writing and Updating: Develop and update TMF plans to ensure up-to-date documentation and adherence to regulatory guidelines.
  • TMF Completion and Quality Monitoring: Conduct regular TMF completion and quality monitoring to identify and address any issues or discrepancies.
  • Collaboration and Communication: Participate in clinical team meetings, provide metrics and TMF progress reports, and offer support and expertise to clinical trial TMF contributors.
  • TMF Review Checks and Corrective Action: Perform TMF review checks, propose corrective action plans, and report any study progress or challenges to the relevant stakeholders.
  • TMF Audits and Document Management: Coordinate the preparation and conduct of TMF audits and complete/create all documents related to TMF management team activities.
What We Offer

As a TMF Management Specialist at Excelya, you will benefit from a stimulating professional environment that encourages personal, intellectual, and operational participation. We commit to giving each team member the means to express their natural talents, develop their full potential, and invest their unique selves in our unique projects.


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