TMF Operations Associate Role Overview
The TMF Operations Associate plays a crucial part in the management of essential documents, ensuring compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This global role involves working closely with project team members to achieve departmental objectives.
Key Responsibilities:
* 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 checks to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Work with various Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Leads to report trends and issues related to the TMF.
* Elevate any TMF Quality concerns 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 different trackers).
Requirements:
* Familiarity with electronic document repositories or eTMFs, along with document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-driven environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Preferred Qualifications:
* University Degree, preferably in Life Sciences.
* 1-2 years of relevant experience.
* Knowledge of working within highly regulated industries.