Associate II, TMF Operations
This role is responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant regulations and industry best practices.
The Associate will support the delivery of department objectives in ensuring the management of essential documents. This is a global role requiring collaboration with Worldwide Project Team members.
The key responsibilities include:
* Processing, reviewing and resolving rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in electronic and hard copy formats.
* Performing periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Working with Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
* Communicating directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalating any TMF Quality issues in a timely manner to RMC Lead.
* Providing administrative support for the RMC Lead including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Requirements:
* Proficiency in use of 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.
Your Qualifications:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)