TMF Operations Associate Role Overview
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The TMF Operations Associate is a vital member of our team, responsible for ensuring the accuracy and compliance of essential documents in our trial master files.
This role requires strong organizational skills, attention to detail, and effective communication to work with colleagues across different departments and locations.
* Process, review, and resolve rejected Trial Master File (TMF) documents, both in electronic and hard copy formats.
* Perform regular quality control checks to ensure adherence to regulatory guidelines, industry best practices, and company standards.
* Work with electronic document management systems to classify, process, and maintain essential documents.
* Communicate with colleagues to report trends and issues related to the TMF.
* Educate others on TMF policies and procedures to ensure consistency and compliance.
Key Responsibilities:
* Document processing and review
* TMF quality control
* Electronic document management
* Collaboration and communication
Requirements:
* Proficiency in electronic document repositories or eTMFs
* Strong interpersonal skills and ability to work in a fast-paced environment
* Sound judgment and decision-making skills
* Microsoft Office skills, including Word and Excel
Preferred Qualifications:
* University degree in a life science field
* 1-2 years of experience in a similar role
* Familiarity with highly regulated industries