Job Title: TMF Operations Associate
The Role:
We are seeking a detail-oriented and organized TMF Operations Associate to join our team. The successful candidate will be responsible for processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This is a global role that requires collaboration with Worldwide Project Team members.
Duties and Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents, including complex studies or Sponsor portfolio of studies 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 the RMC Lead to report trends and issues relevant to the TMF.
* Evaluate any TMF Quality issues in a timely manner and escalate them to the RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Requirements and Qualifications:
* A university degree is preferred, preferably in Life Science.
* 1-2 years of relevant experience is required.
* Proficiency in the use of an electronic document repository or eTMF, as well as document recognition skills.
* Strong interpersonal skills for working in a fast-paced, deadline-oriented environment.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.