**Job Summary:**
We are seeking a highly skilled Associate II to join our team in TMF Operations.
The successful candidate will be responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices.
This is a global role requiring collaboration with Worldwide Project Team members.
Main Responsibilities:
* Process, review and resolve rejected Trial Master File (TMF) documents, both in electronic and hard copy formats, for complex studies or Sponsor portfolio of studies.
* Perform periodic TMF 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 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 (TMF Quality Control checklists and different trackers).
Key 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 and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Requirements Overview:
* University Degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry desirable.