Job Overview
The Associate II, TMF Operations plays a vital role in ensuring the accuracy and integrity of essential documents in compliance with regulatory standards. This global position requires collaboration with Worldwide Project Team members to deliver department objectives.
Main Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Utilize Electronic Document Management systems 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.
* Educate on 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.
Key Requirements
* Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Preferred Qualifications
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.