Job Title: Document Management Specialist
About the Role
The Document Management Specialist is responsible for processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Key Responsibilities
* Process and review Trial Master File (TMF) documents, including complex studies or Sponsor portfolios, 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 Electronic Document Management systems and eTMF systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF Quality issues in a timely manner to RMC Lead.
* Provide administrative support to RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in using electronic document repositories and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented environments.
* 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 highly regulated industries (desirable).