Avania is the only global CRO built for MedTech — integrating regulatory strategy, clinical development, and market access and reimbursement to take innovations from concept to commercialization with confidence. Avania was purpose-designed to serve medical technology innovators, combining regulatory, clinical, engineering, and market access expertise to guide products across the full lifecycle
Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.
Avania - MedTech's trusted Champion
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!
Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
#LI-DNI
Full, Comprehensive Benefits3-5 years eTMF/CTMS experience, proficiency with Microsoft tools including SharePoint, experience with Veeva Vault preferred, ability to resolve documentation queries and communicate progress.
Key Responsibilities
- performing TMF quality control
- supporting CTMS operations
- coordinating project activities
Skills & Tools
Microsoft SharePoint, Veeva Vault, Medidata Rave, Sitero, Smartsheet
Job Details
- Category: Project and Program Management
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — United States
- Salary: USD 70,000 – 70,000 / year
- Languages: English
About Avania
A global CRO integrating regulatory strategy, clinical development, and market access for medical technology. — Industry: Research and Development