TM Operations Associate Role
As a TMF Operations Associate, you will play a critical role in ensuring the timely and accurate processing, maintaining, and archiving of essential documents in compliance with regulatory requirements and industry best practices.
Key Responsibilities:
* Process and review Trial Master File (TMF) documents, including electronic and hard copy formats, to ensure adherence to regulatory and industry standards.
* Perform periodic quality control checks on TMFs to identify trends and issues, and escalate any quality concerns to the RMC Lead in a timely manner.
* Collaborate with various Electronic Document Management and eTMF systems to review, classify, and process essential documents.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements:
* Proficiency in using electronic document repositories or eTMFs, 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.
About You:
* University degree preferred, preferably in a life science field.
* 1-2 years of relevant experience in a highly regulated industry.
* Able to work effectively in a global team environment.