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Zusammenfassung
A leading clinical research organization in Canada is seeking a TMF Coordinator to manage Trial Master File processes throughout the study lifecycle. The ideal candidate will have a college diploma and 1-3 years of relevant experience, emphasizing TMF organization and regulatory compliance. Responsibilities include ensuring the TMF is complete and ready for inspection, providing training, and maintaining quality assurance standards. This full-time role offers the flexibility to work from home with occasional office visits.
Qualifikationen
1-3 years of experience related to TMF or ongoing training.
Strong understanding of TMF regulations and quality assurance.
Ability to apply ALCOA principles in TMF oversight.
Aufgaben
Manage the Trial Master File content and processes.
Ensure TMF is complete and inspection-ready.
Train internal and external stakeholders on TMF processes.
Kenntnisse
TMF organization
Problem-solving
Time management
Computer literacy
Ausbildung
College diploma/degree
Tools
Microsoft Office
Jobbeschreibung
A leading clinical research organization in Canada is seeking a TMF Coordinator to manage Trial Master File processes throughout the study lifecycle. The ideal candidate will have a college diploma and 1-3 years of relevant experience, emphasizing TMF organization and regulatory compliance. Responsibilities include ensuring the TMF is complete and ready for inspection, providing training, and maintaining quality assurance standards. This full-time role offers the flexibility to work from home with occasional office visits.
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