Clinical Document Lead

1 week ago


Brisbane, Queensland, Australia beBeeManager Full time $100,000 - $150,000
Job Description

This is an exciting opportunity to lead our Vaccine Clinical Documentation Platform as a Trial Master File (TMF) Manager. You will play a crucial part in overseeing and managing the TMF for assigned clinical trials, ensuring compliance with ICH-GCP standards and internal processes.

The selected candidate will be responsible for setting up, overseeing, and locking clinical TMFs for assigned studies, ensuring the quality of Clinical Department Trial Master Files at all times, leading TMF kick-off meetings with clinical teams and CROs, writing, maintaining, and updating TMF Plans throughout the study lifecycle, and monitoring TMF quality and completeness, providing metrics, reports, and remediation plans when needed.



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