eTMF Specialist, Pharma, BiAnnual Review Project
Anywhere
Category: Clinical Ops
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -082026-108200
Date Posted: 08/06/2026
Shortcut: http://careers.eliassen.com/o42SFh
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-GCP 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.
Experience Requirements:
- 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-GCP 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.
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 Eliassen.com 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 fraud@eliassen.com.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contact fraud@eliassen.com.
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 Eliassen.com 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, as indicated above