
About Me
Responsible for efficient and appropriate management of Trial Master Files TMF and other TMF related, inspection relevant documents from creation through archival in compliance with applicable SOPs, processes and study specific requirements for assigned trials according to established timelines.
Current Job Responsibilities:
Drive TMF Quality at trial level:
* Provide subject matter expertise, ensures compliance with TMF processes and tools and promotes
awareness of the importance of a high quality TMF
* Support the definition and refinement of the document management strategy for TMFs within
each assigned Clinical Trial Team.
* Promote best documentation practice to line functions and provide guidance on document
standards for the business functions to support inspection readiness and adherence to Good
Documentation Practice.
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