Job Title

What the Associate II, TMF Operations does at WorldwideThe Associate II, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice. The Associate will support the delivery of department objectives in ensuring the management essential documents. This is a global role and will require working with Worldwide Project Team members.What you will doProcess, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.Work with a variety of 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.Escalate any TMF Quality issues in a timely manner to RMC Lead.Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).What you will bring to the roleProficiency in use of an electronic document repository or eTMF, and document recognition skills.Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environmentSound judgment and ability to identify decisions requiring supervisory approval.Proficiency in Microsoft Word and Excel.Your experienceUniversity Degree preferred (Life Science desirable)1-2 years of relevant experienceKnowledge of working within a highly regulated industry (desirable)