Job Summary
This role involves the processing, maintenance and archiving of all essential documents in compliance with relevant regulations and industry best practices. The Associate II will support the delivery of department objectives in ensuring the management of essential documents.
This is a global role requiring collaboration with team members worldwide.
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, ICH GCP, Sponsor and industry best practices.
* Work with 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 related to the TMF.
* Evaluate TMF Quality issues and escalate them in a timely manner to RMC Lead.
Requirements:
* Proficiency in using 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.