About the Role
The Associate II, TMF Operations is responsible for managing essential documents in compliance with regulatory requirements and industry best practices. This global role involves working with a team to ensure the timely delivery of department objectives.
Key Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic quality control checks to ensure adherence to regulatory and industry standards.
* Review and classify documents using various Electronic Document Management systems.
* Communicate with team leads to report trends and issues relevant to the TMF.
* Evaluate and escalate any quality issues related to the TMF in a timely manner.
Required Skills and Qualifications
* Proficiency in using electronic document repositories or eTMF systems and document recognition skills.
* Strong interpersonal skills and ability to work effectively in fast-paced environments.
* Sound judgment and decision-making skills with minimal supervision.
* Proficiency in Microsoft Word and Excel applications.
Your Background
* University degree preferred, preferably in Life Sciences.
* 1-2 years of relevant experience in a highly regulated industry.