**Job Overview**
This role is focused on ensuring the accurate and timely processing, maintenance, and archiving of essential documents in compliance with regulatory requirements.
* The successful candidate will support the delivery of department objectives by managing essential documents, working closely with project team members, and adhering to industry best practices.
Key Responsibilities:
The Associate II, TMF Operations will be responsible for the following tasks:
* TMF Document Processing: Review, classify, and process essential documents in both electronic and hard copy formats, ensuring adherence to regulatory standards and industry best practices.
* TMF Quality Control: Perform regular quality checks to ensure that documents meet the required standards, identify trends and issues, and escalate them to the RMC Lead in a timely manner.
* Document Management: Utilize electronic document management systems and eTMF platforms to review, classify, and process essential documents, as well as provide administrative support for the RMC Lead, including filing and maintaining internal documents.
The ideal candidate will possess strong interpersonal skills, sound judgment, and the ability to identify decisions requiring supervisory approval.
Requirements:
To be successful in this role, the candidate should have:
* Proficiency in eTMF Systems:** Experience in using electronic document repositories or eTMF systems and document recognition skills.
* Strong Interpersonal Skills:** Ability to work effectively in a fast-paced, deadline-oriented environment and communicate directly with the RMC Lead.
* Judgment and Decision-Making:** Sound judgment and ability to identify decisions requiring supervisory approval.
* Technical Skills:** Proficiency in Microsoft Word and Excel.
The successful candidate will possess a university degree (Life Science desirable), 1-2 years of relevant experience, and knowledge of working within a highly regulated industry.