Job Summary:
The Associate II, TMF Operations plays a pivotal role in ensuring the seamless management of essential documents. As part of our global team, you will be responsible for processing, maintaining, and archiving critical 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 portfolios in both electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Leads to report trends and issues relevant to the TMF.
* Educate RMC Leads on potential TMF Quality issues in a timely manner.
* Provide administrative support to RMC Leads, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
About You:
* Proficiency in using an electronic document repository or eTMF, and document recognition skills are necessary.
* You should possess strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and the ability to identify decisions requiring supervisory approval are essential.
* Proficiency in Microsoft Word and Excel is also required.
Your Background:
* A University Degree is preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry is desirable