Job Description
This role is responsible for ensuring the accuracy and integrity of trial master files in compliance with regulatory requirements.
The Associate II, TMF Operations will process, review, and resolve rejected documents, perform quality control checks, and work with electronic document management systems to classify and process essential documents.
* Process, review, and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats.
* Perform periodic Quality Control to ensure adherence to regulatory, ICH GCP, and industry best practices.
* Work with Electronic Document Management Systems to review, classify, and process Essential Documents.
Key Responsibilities
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalate any TMF Quality issues in a timely manner to RMC Lead.
* Provide administrative support for the RMC Lead including filing and maintaining internal documents.
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.
Qualifications
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.