As a key member of our global team, this role is responsible for ensuring the seamless processing, maintenance, and archiving of all essential documents in compliance with regulatory requirements, industry best practices, and company standards. The Associate II, TMF Operations will play a vital part in delivering department objectives by guaranteeing the effective management of essential documents.
This is a global role requiring collaboration with Worldwide Project Team members to ensure the successful implementation of processes and procedures.
* Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
* 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 RMC Lead to report trends and issues relevant to the TMF.
* Evaluate any TMF Quality issues in a timely manner and escalate them to RMC Lead.
* Provide administrative support for the RMC Lead including but not limited to 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.
Qualifications
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)