Job Title: Document Control Specialist
This role is responsible for the processing, maintaining and archiving of all essential documents in compliance with regulatory requirements and industry best practices.
The ideal candidate will support the delivery of department objectives by ensuring the management of essential documents. This is a global role requiring collaboration with Worldwide Project Team members.
Key Responsibilities:
* Process, review and resolve rejected 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 and eTMF Systems to review, classify and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalate 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).
Required Skills and Qualifications:
* Proficiency in use of 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.
Preferred Qualifications:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable)