Job Description:
The Associate II, TMF Operations role is responsible for ensuring the processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio 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.
* 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 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 different trackers).
Requirements:
* Proficiency in using an electronic document repository or eTMF and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented, rapidly changing environments.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Preferred Qualifications:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within highly regulated industries (desirable)