TMF Operations Associate
Responsible for the processing, maintaining, and archiving of essential documents in compliance with relevant SOPs, ALCOA principles, country regulations, and industry best practices.
* Process and review rejected Trial Master File (TMF) documents, both in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry standards.
* Review, classify, and process Essential Documents using Electronic Document Management and eTMF Systems.
* Communicate with RMC Lead to report trends and issues relevant to the TMF.
* Elevate TMF Quality issues to RMC Lead in a timely manner.
Support the RMC Lead in administrative tasks, including filing and maintaining internal documents on study SharePoint.
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