About the Role
The Associate II, TMF Operations is responsible for processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This global role requires working with Worldwide Project Team members to ensure the management of essential documents.
Key Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents, both 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 directly with RMC Lead to report trends and issues relevant to the TMF.
* Elevate any TMF Quality issues to RMC Lead 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 highly regulated industries (desirable).