Job Title: Document Operations Specialist
About the Role:
The Document Operations 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.
This role supports the delivery of department objectives by ensuring the management of essential documents. It is a global position requiring collaboration with worldwide project team members.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents, both in electronic and hard copy formats, for complex studies or sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Utilize various 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.
* Educate RMC Lead on any TMF Quality issues in a timely manner.
* 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 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.
Your Experience:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)