TMF Operations Role
The Associate II, TMF Operations position involves the processing, maintenance, and archiving of essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This global role requires collaboration with Worldwide Project Team members to ensure the management of essential documents.
* Process, review, 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.
* Utilize Electronic Document Management systems and eTMF Systems to review, classify, and process Essential Documents.
* Communicate trends and issues related to the TMF with RMC Lead.
* Escalate TMF Quality issues to RMC Lead in a timely manner.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements for Success
* Proficiency in using electronic document repositories or eTMF 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.
Background and Experience
* University Degree preferred, with Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is advantageous.