TMF Operations Associate II Job Summary
">
This is a global role that requires working with project team members to ensure the management of essential documents in compliance with regulatory, ICH GCP, sponsor, and industry best practices.
">
Main Responsibilities:
">
">
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or sponsor portfolios.
">
* Perform periodic quality control checks on TMFs to ensure adherence to regulatory and industry standards.
">
* Work with various electronic document management systems to review, classify, and process essential documents.
">
* Communicate trends and issues related to TMFs with RMC Leads and escalate quality issues in a timely manner.
">
* Provide administrative support to RMC Leads, 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 fast-paced, deadline-oriented environments.
">
* Sound judgment and ability to identify decisions requiring supervisory approval.
">
* Proficiency in Microsoft Word and Excel.
">
* University degree preferred, with life science desirable.
">
* 1-2 years of relevant experience, with knowledge of highly regulated industries desirable.
">
">
About This Role:
">
This role involves processing, reviewing, and resolving rejected TMF documents to ensure compliance with regulatory and industry standards. The successful candidate will work closely with project team members to deliver high-quality results and meet deadlines.
">
The ideal candidate will have excellent communication skills, strong attention to detail, and the ability to work effectively in a team environment. They will also possess sound judgment and be able to identify decisions requiring supervisory approval.
">
As a TMF Operations Associate II, you will play a crucial role in ensuring the smooth operation of our team and contributing to the delivery of high-quality results.
"],