Job Description:
TMF Operations Associate Role
This role is responsible for ensuring the timely and accurate processing, maintaining, and archiving of essential documents in compliance with regulatory requirements, industry best practices, and company standards.
The TMF Operations Associate will support the delivery of departmental objectives by maintaining and updating electronic document management systems, reviewing and resolving rejected documents, and performing periodic quality control checks to ensure adherence to regulations and industry standards.
* Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF quality issues in a timely manner to RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
About You
To be successful in this role, you will require strong interpersonal skills, proficiency in the use of electronic document repositories or eTMF systems, and document recognition skills.
You should have sound judgment and ability to identify decisions requiring supervisory approval. Proficiency in Microsoft Word and Excel is also essential.
* Requirements:
* University degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)