Job Title: Document Operations Specialist
About the Role
The Associate II, TMF Operations is a critical position responsible for processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices. This role requires collaboration with the Worldwide Project Team to support department objectives and ensure effective management of essential documents.
Key Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios, both in electronic and hard copy formats.
* 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.
* Evaluate and escalate any 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 (TMF Quality Control checklists and different trackers).
Requirements
* Proficiency in using an electronic document repository or eTMF and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background
* University Degree preferred, with a Life Science degree being desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is beneficial.