Job Title: Document Management Specialist
An exciting opportunity has arisen for a highly organized and detail-oriented individual to join our team as a Document Management Specialist. In this role, you will be responsible for the processing, maintaining, and archiving of essential documents in compliance with regulatory requirements and industry best practices.
Main 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, ICH GCP, and industry standards.
* Work with electronic document management systems to review, classify, and process essential documents.
* Communicate directly with stakeholders to report trends and issues relevant to the TMF.
* Educate others on document management procedures and policies.
Required Skills and Qualifications:
* Proficiency in using electronic document repositories or eTMFs.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
About You:
* University degree preferred, life science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.