Job Title: Document Operations Specialist
Job Summary
This role involves processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Main Responsibilities
* Process and review rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios of studies 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 Leads to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF Quality issues in a timely manner to RMC Leads.
* Provide administrative support for RMC Leads, 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 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).