About TMF Operations Associate II
The role of a TMF Operations Associate II involves the processing, maintenance, and archiving of essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices. The Associate will support department objectives in ensuring efficient management of essential documents. This global role requires working with Worldwide Project Team members.
Key Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios of studies in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Utilize 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.
* Educate team members on TMF quality issues and provide administrative support for the RMC Lead including filing and maintaining internal documents on study SharePoint.
Requirements and Qualifications
* 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.
Preferred Education and Experience
* University degree preferred, with Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is beneficial.