Job Overview
The Associate II, TMF Operations role is responsible for the management of essential documents in compliance with regulatory requirements and industry best practices.
This global position requires working with project teams to ensure the delivery of department objectives.
* Key Responsibilities:
* Process and review Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic quality control checks to ensure adherence to regulatory and industry standards.
* Collaborate with electronic document management systems to review and classify essential documents.
* Communicate with RMC Leads to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF quality issues in a timely manner.
* Provide administrative support to RMC Leads including filing and maintaining internal documents.
Requirements
* Education: University degree preferred (Life Science desirable)
* Experience: 1-2 years of relevant experience
* Skillset: Proficiency in electronic document repositories, document recognition skills, strong interpersonal skills, sound judgment, and proficiency in Microsoft Word and Excel