The Role of an Associate II, TMF Operations
Job Summary:
This is a global role that requires the processing, maintaining and archiving of all essential documents in compliance with regulatory requirements. The successful candidate will support the delivery of department objectives and ensure the management of essential documents.
Key Responsibilities:
* Process, review and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in both 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 systems to review, classify and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Evaluate and escalate any TMF Quality issues in a timely manner to RMC Lead.
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.
* Proficiency in Microsoft Word and Excel.
About Us:
This role offers an opportunity to work in a highly regulated industry and contribute to the success of our organization.