About the Role
This position involves supporting the management of essential documents in compliance with regulatory requirements. The role requires processing, reviewing, and resolving rejected documents, as well as performing quality control checks to ensure adherence to industry best practices.
Key Responsibilities
* Process and review electronic and hard copy Trial Master File (TMF) documents for complex studies or Sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory and industry standards.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate trends and issues relevant to the TMF to the RMC Lead.
* Evaluate TMF Quality issues and escalate them to the RMC Lead in a timely manner.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in using an electronic document repository or eTMF, and document recognition skills are necessary.
* A strong understanding of interpersonal skills is required to work effectively in a fast-paced environment.
* The ability to exercise sound judgment and identify decisions requiring supervisory approval is essential.
* Proficiency in Microsoft Word and Excel is also required.
Education and Experience
* A university degree, preferably in Life Sciences, is preferred.
* 1-2 years of relevant experience working within a highly regulated industry is desired.