**Job Overview**
The Associate II, TMF Operations role is responsible for the processing, maintaining and archiving of essential documents in compliance with relevant standards, regulations and best practices.
This global position involves working with Worldwide Project Team members to ensure the management of essential documents.
* Key Responsibilities:
* Process and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats 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 and electronic TMF Systems to review, classify and process Essential Documents.
* Communicate trends and issues related to the TMF to RMC Lead.
* Evaluate and escalate TMF Quality issues in a timely manner.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented 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.
* Knowledge of working within a highly regulated industry (desirable).