Job Overview
As a TMF Operations Associate II, you will play a vital role in ensuring the compliance and quality of essential documents in various studies. Your responsibilities will include processing, reviewing, and resolving rejected Trial Master File (TMF) documents, performing periodic Quality Control to ensure adherence to regulatory and industry best practices, and working with Electronic Document Management Systems to review and process Essential Documents.
Main Responsibilities:
* Process and review rejected TMF documents for complex studies or Sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with Electronic Document Management Systems to review and classify Essential Documents.
Required Skills and Qualifications:
* Proficiency in using electronic document repositories or eTMFs, and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
Your Experience:
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).