TMF Operations Associate
The TMF Operations Associate plays a crucial role in ensuring compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios 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.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Leads to report trends and issues relevant to the TMF.
* Elevate any TMF Quality issues to RMC Leads in a timely manner.
* Provide administrative support for RMC Leads, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Required Skills and Qualifications
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Experience
* University degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within highly regulated industries (desirable).
About This Role
This is a global role that requires collaboration with Worldwide Project Team members. The successful candidate will possess excellent communication and organizational skills, as well as a strong understanding of regulatory requirements and industry best practices.