Job Description:
The Associate II, TMF Operations role involves processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This position is responsible for supporting the delivery of department objectives by ensuring the management of essential documents. The role requires collaboration with Worldwide Project Team members.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios in both electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Elevate 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.
Requirements:
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Qualifications:
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).