TMF Operations Specialist
Position Overview
The Associate II, TMF Operations plays a vital role in ensuring the management of essential documents.
Key Responsibilities:
• Process and review rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies in electronic and hard copy formats.
• Conduct periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
• Collaborate 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.
• 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 on study SharePoint (TMF Quality Control checklists and different trackers).
Required Skills and Qualifications:
• Proficiency in using an electronic document repository or eTMF, and document recognition skills.
• Strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment.
• Sound judgment and ability to identify decisions requiring supervisory approval.
• Proficiency in Microsoft Word and Excel.
• University Degree preferred (Life Science desirable)
• 1-2 years of relevant experience
• Knowledge of working within a highly regulated industry (desirable)
Benefits:
You will have the opportunity to work with a variety of Electronic Document Management and electronic TMF Systems. This role requires strong communication skills and the ability to work effectively in a team environment.