Job Overview
This role involves the management of essential documents in compliance with regulatory requirements, industry best practices, and company policies.
Key Responsibilities:
* Process and review rejected Trial Master File (TMF) documents for complex studies or sponsor portfolios in both electronic and hard copy formats.
* 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 the RMC Lead to report trends and issues relevant to the TMF.
* Evaluate any TMF Quality issues in a timely manner and escalate them to the 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).
Requirements and Qualifications
* 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.
Education and Experience
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)