TMF Operations Associate Role Overview
The TMF Operations Associate is a crucial member of our team, responsible for ensuring the efficient processing and maintenance of essential documents.
This global role requires collaboration with project team members to achieve department objectives.
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Conduct regular quality control checks to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Work with various electronic document management systems to review, classify, and process essential documents.
* Communicate with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate TMF quality issues to the RMC Lead in a timely manner.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents on SharePoint.
Requirements for Success
To excel in this role, you will need:
* Proficiency in using an electronic document repository or eTMF, as well as strong document recognition skills.
* Excellent interpersonal skills, capable of handling a fast-paced environment.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background
We are seeking candidates with:
* A university degree, preferably in a life science field.
* 1-2 years of relevant experience.
* Familiarity with working within a highly regulated industry.