TMF Operations Associate Role
The primary focus of this role is to ensure the timely and accurate processing, maintenance, and archiving of essential documents in compliance with relevant SOPs, ALCOA principles, country regulations, and industry best practices.
This position plays a critical role in supporting the delivery of department objectives by ensuring the effective management of essential documents. As a global role, it requires collaboration with Worldwide Project Team members.
Key Responsibilities:
* Process and review rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios in both electronic and hard copy formats.
* Perform periodic TMF Quality Control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Utilize 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.
* Elevate any TMF Quality issues in a timely manner to RMC Leads.
* Provide administrative support for RMC Leads, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and trackers).
Required Skills and Qualifications:
* Proficiency in using electronic document repositories or eTMFs and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented environments.
* Sound judgment 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 highly regulated industries (desirable)