Job Overview
The Associate II, TMF Operations role involves ensuring the management of essential documents in compliance with relevant SOPs and regulations. This position requires a global perspective, working closely with worldwide project team members to achieve department objectives.
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 and industry best practices.
* Work with various Electronic Document Management 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 to RMC Lead in a timely manner.
* Provide administrative support to 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 required.
* Strong interpersonal skills in fast-paced, deadline-oriented environments are necessary.
* Sound judgment to identify decisions requiring supervisory approval is essential.
* Proficiency in Microsoft Word and Excel is required.
Your Background
* A University Degree is preferred, especially in Life Sciences.
* 1-2 years of relevant experience is required.
* Knowledge of working within a highly regulated industry is desirable.
About this Role
This role requires a professional who can work independently and as part of a global team. A strong understanding of regulatory requirements and industry best practices is necessary. If you have a passion for documentation and quality control, this could be the ideal opportunity for you.