About the Role
The Associate II, TMF Operations is a critical position within our organization responsible for ensuring the integrity and compliance of essential documents.
This global role requires collaboration with Worldwide Project Team members to support department objectives and ensure the management of essential documents.
* Process, review, and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Utilize Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF Quality issues 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.
* 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 Background
* University Degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Familiarity with working within a highly regulated industry is advantageous.