Associate II, TMF Operations
We are seeking a skilled and detail-oriented Associate II to join our team in a global role. The successful candidate will be responsible for processing, maintaining, and archiving essential documents in compliance with regulatory requirements, industry best practices, and company standards.
The Associate II, TMF Operations, will support the delivery of department objectives by ensuring the management of essential documents. This role requires excellent communication skills, as you will work closely with Worldwide Project Team members.
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 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 staff on procedures to maintain high-quality documentation.
Requirements:
Education: University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)
* Proficiency in use of 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