Job Overview
The Associate II, TMF Operations role involves the processing, maintaining, and archiving of essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices. This position requires collaboration with a global team to ensure seamless delivery of department objectives.
Main Responsibilities
Key responsibilities include:
* Reviewing and resolving rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in electronic and hard copy formats.
* Performing periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Working with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicating directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalating any TMF Quality issues in a timely manner to RMC Lead.
* Providing administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Required Skills and Qualifications
To excel in this role, you should possess:
* 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.
Your Experience
A successful candidate should have:
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).