The Role of a Document Operations Specialist
This role involves ensuring the management of essential documents in compliance with regulatory requirements and industry best practices.
* Document Review and Resolution: Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios in both electronic and hard copy formats.
* TMF Quality Control: Perform periodic quality control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry standards.
* Electronic Document Management: Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communication: Communicate directly with team leads to report trends and issues relevant to the TMF.
* TMF Quality Issues: Escalate any TMF quality issues in a timely manner to team leads.
Administrative Support: Provide administrative support to team leads, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in using electronic document repositories or eTMFs and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Preferred Qualifications
* University degree in a life science field.
* 1-2 years of experience in a related field.
* Knowledge of working within a highly regulated industry.
This role requires strong organizational and time management skills, as well as the ability to work independently and as part of a team.