Job Description
Role Overview
The Associate II, TMF Operations plays a crucial role in ensuring the management of essential documents. This is a global position that requires collaboration with Worldwide Project Team members.
Main Responsibilities
* Document Processing: Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios in both electronic and hard copy formats.
* TMF Quality Control: Perform periodic quality control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Electronic Document Management: Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communication: Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* TMF Quality Issues: Escalate any TMF Quality issues in a timely manner to RMC Lead.
* Administrative Support: Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Requirements
* Proficiency in eTMF and Document Recognition: Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Interpersonal Skills: Strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment.
* Judgment and Decision Making: Sound judgment and ability to identify decisions requiring supervisory approval.
* Technical Skills: Proficiency in Microsoft Word and Excel.
Education and Experience
* University Degree: University Degree preferred (Life Science desirable)
* Relevant Experience: 1-2 years of relevant experience.
* Regulated Industry Knowledge: Knowledge of working within a highly regulated industry (desirable)