The Associate II, TMF Operations role supports the management of essential documents in compliance with regulations and industry best practices.
This is a global position requiring collaboration with Worldwide Project Team members.
Key responsibilities include:
* Processing, reviewing, and resolving rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios.
* Performing periodic TMF Quality Control to ensure adherence to regulatory requirements.
* Working with Electronic Document Management systems to review, classify, and process Essential Documents.
* Communicating with RMC Leads to report trends and issues relevant to the TMF.
Requirements for success in this role include:
* Proficiency in using electronic document repositories and document recognition skills.
* Strong interpersonal skills in fast-paced environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
An ideal candidate would possess a University Degree, preferably in Life Sciences, and 1-2 years of relevant experience working within highly regulated industries.