TMF Operations Associate Role
The TMF Operations Associate is a crucial member of our team, responsible for ensuring the timely and accurate processing of trial master file documents. This role requires strong organizational skills, attention to detail, and excellent communication abilities.
Key Responsibilities:
* Process, review, and resolve rejected trial master file 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 and eTMF tools to review, classify, and process essential documents.
* Communicate effectively with project leads to report trends and issues related to the trial master file.
* Escalate quality concerns to project leads in a timely manner.
Requirements:
* Proficiency in using electronic document repositories or eTMF systems.
* Strong interpersonal skills for working in a fast-paced environment.
* Sound judgment for identifying decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
About You:
* A university degree in life sciences is preferred but not required.
* 1-2 years of relevant experience in a highly regulated industry.
This role offers opportunities for growth and development in a dynamic environment.