About the Role
The Associate II, TMF Operations is responsible for processing, maintaining and archiving all essential documents in compliance with relevant SOPs, ALCOA principles, country regulations and industry best practices.
This role supports the delivery of department objectives by ensuring the management of essential documents. As a global position, it requires collaboration with Worldwide Project Team members.
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 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 in a timely manner to 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).