Project Coordinator

Avania are  hiring - Project Coordinator - eTMF/CTMS Specialist

Salary up to $70,000 + Annual Bonus + Benefits 

About the Role

Join Avania in a US-based 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.

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply. With our continued growth we are hiring talent to join us on our journey and grow with us.

What You'll Bring

• Hands-on experience in eTMF/CTMS work, including TMF filing, quality control, and resolving documentation queries. We're looking for someone with around 3-5 years of relevant experience who is comfortable working in these systems.

• The ability to follow a documentation quality issue through to resolution and communicate progress clearly.

• Proficiency with Microsoft tools, including SharePoint.

Experience with Veeva Vault is particularly valuable. Familiarity with Medidata Rave, Sitero and other eTMF/CTMS platforms would also be helpful. Smartsheet experience is a plus, not a requirement.

Avania - MedTech's trusted Champion 

We look forward to receiving your application!

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