Job Description
The Associate II, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice.
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.
Duties and Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Utilize Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate with RMC Lead on trends and issues related to the TMF.
* Escalate TMF Quality issues to RMC Lead in a timely manner.
* Provide administrative support to the RMC Lead, including filing and maintaining internal documents on SharePoint.
Required Skills and Qualifications
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within highly regulated industries (desirable)