More jobs:
ETMF Specialist, Pharma, BiAnnual Review Project
Job in
Almont, Gunnison County, Colorado, 81210, USA
Listed on 2026-08-07
Listing for:
Eliassen Group
Full Time
position Listed on 2026-08-07
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Description:
Remote
Our client is seeking an eTMF Specialist to support a biannual review of Phase III Trial Master Files. The specialist will ensure TMFs are complete, accurate, compliant, and inspection-ready through comprehensive quality review and collaboration with internal and external stakeholders.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $65.00 to $75.00/hr. w2
Responsibilities:
- Conduct comprehensive biannual reviews of three Phase III Trial Master Files across assigned clinical studies to assess completeness, accuracy, quality, and inspection readiness.
- Perform risk-based reviews by comparing expected versus filed TMF content, identifying missing, incomplete, duplicate, or incorrectly filed documents, and documenting review findings.
- Collaborate with Clinical Operations, CROs, vendors, and cross-functional study teams to investigate TMF gaps and facilitate timely remediation activities.
- Ensure TMF documentation and review activities comply with SOPs, TMF Plans, the DIA TMF Reference Model, ICH-Google Cloud Platform guidelines, and applicable global regulatory requirements.
- Support inspection readiness efforts by verifying the availability, completeness, and quality of critical TMF documentation throughout the TMF lifecycle.
- Maintain review documentation, issue logs, quality review records, and supporting evidence in accordance with internal quality procedures.
- Communicate review progress, findings, risks, and recommendations to the designated project lead on a regular basis.
- Demonstrated sponsor-side experience in TMF management and quality review within the biotechnology or pharmaceutical industry.
- Strong working knowledge of the DIA TMF Reference Model.
- Thorough understanding of ICH-Google Cloud Platform guidelines and applicable regulatory requirements governing clinical trial documentation.
- Experience preparing and maintaining inspection-ready TMFs.
- Ability to work independently and collaborate with internal team members and external partners.
- Excellent organizational skills and attention to detail.
Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position.
All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
When you work with Eliassen Group, all email communication will come from an address, never Gmail, Yahoo, etc.
Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact .
About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the…
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