Job Title
Document Operations Specialist
-----------------------------------
About the Role
We are seeking a skilled Document Operations Specialist to join our team. This role is responsible for the processing, maintaining and archiving of all essential documents in compliance with regulatory requirements.
-----------------------------------
Key Responsibilities
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory and industry best practices.
* Work with 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.
-----------------------------------
Requirements
* Proficiency in use of an electronic document repository or eTMF, 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.
-----------------------------------
Education and Experience
University Degree preferred (Life Science desirable). 1-2 years of relevant experience. Knowledge of working within a highly regulated industry (desirable).