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Avania

Project Coordinator

Posted 7 days ago
2-5 years experience
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AI Summary

Conduct independent TMF quality control reviews, identify and resolve documentation issues through queries, and support TMF filing, cleanup, and transfers using eTMF and CTMS platforms. Report review progress and provide project coordination support, including training assignments, meeting documentation, and improvements to internal quality control processes.

Avania are  hiring - Project Coordinator - eTMF/CTMS Specialist 

About the Role

Join Avania in a remote role focused on electronic Trial Master File (eTMF) quality control and Clinical Trial Management System (CTMS) support. You'll help improve the quality of trial documentation across client projects and Avania-managed studies, working with project managers and project coordinators to identify and resolve documentation issues.

The role combines specialist eTMF/CTMS work with some project coordination responsibilities. Its primary focus is independent TMF quality control, separating document review from the work of uploading and filing documents.

What You'll Do

  • Perform TMF quality control reviews, identify documentation issues, and issue, respond to, and follow up on queries through resolution.
  • Support TMF filing, cleanup, and transfers, with final transfer sign-off retained by the senior specialist.
  • Work in eTMF and CTMS platforms to support trial documentation and study teams.
  • Report concise progress metrics, including time spent and documents or folders reviewed.
  • Support project coordination as needed, including assigning training, preparing meeting agendas and minutes, and maintaining accompanying meeting logs.
  • Help improve internal TMF quality control processes alongside project managers, project coordinators, and the senior specialist.

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