Job Description:
The Associate II, TMF Operations role is responsible for processing, maintaining, and archiving essential documents in compliance with regulatory requirements, industry best practices, and Standard Operating Procedures. This involves supporting the delivery of department objectives by ensuring the management of essential documents.
Key Responsibilities:
* Process and review Trial Master File (TMF) documents, resolving rejected documents in electronic and hard copy formats.
* Perform periodic Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate TMF Quality issues to RMC Lead in a timely manner.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and trackers).
Required Skills and Qualifications:
* Proficiency in using an electronic document repository or eTMF, along with document recognition skills.
* Strong interpersonal skills for working in a fast-paced, deadline-oriented environment.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background:
* A university degree is preferred, particularly in Life Sciences.
* 1-2 years of relevant experience is required.
* Knowledge of working within a highly regulated industry is desirable.