Job Overview
TMF Operations Associate II Role Summary
This position is responsible for ensuring the processing, maintenance, and archiving of essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate TMF quality issues and escalate them to RMC Lead in a timely manner.
* Provide administrative support to RMC Lead including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and trackers).
About You
Requirements:
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background
* University degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Familiarity with working within highly regulated industries.