eTMF Specialist / Clinical Trial Management Associate
Anywhere
Category: Clinical Ops
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -062026-107246
Date Posted: 06/03/2026
Shortcut: http://careers.eliassen.com/03Pmqj
Description:
Remote
Our client seeks an experienced eTMF Specialist / Clinical Trial Management Associate to support Clinical Operations after a recent migration to Veeva Vault eTMF. The role will focus on eTMF oversight, process development, and inspection readiness while providing CTMA-level study support. The position reports to the Clinical Operations Study Lead.
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: $62.00 to $72.00/hr. w2
JN -062026-107246
Responsibilities:
- Serve as internal subject matter expert for Veeva Vault eTMF.
- Lead development and implementation of new eTMF processes, standards, and best practices following system migration.
- Conduct ongoing quality reviews of eTMF content to ensure completeness, timeliness, and compliance.
- Perform system-level data reviews and health checks.
- Ensure TMF is audit and inspection ready at all times.
- Provide guidance and training to Clinical Operations staff on proper document filing and system use.
- Identify process gaps and recommend continuous improvement solutions.
- Support overall TMF quality and compliance initiatives.
- Support assigned studies under the direction of the Study Lead.
- Conduct data listing reviews and identify trends or discrepancies.
- Review monitoring trip reports for quality and completeness.
- Provide operational oversight and study-level support as needed.
- Assist with study documentation, tracking, and compliance activities.
- Collaborate cross-functionally to ensure study timelines and deliverables are maintained.
Experience Requirements:
- 6 to 8 years of experience in clinical research or clinical operations.
- 3 to 5 years of hands-on experience with Veeva Vault eTMF.
- Proven experience establishing or optimizing eTMF processes.
- Thorough understanding of inspection readiness and TMF quality expectations.
- Prior experience in a Clinical Trial Manager, Senior CRA, or equivalent clinical operations role.
- Experience reviewing monitoring reports and data listings.
- Strong understanding of GCP and regulatory compliance requirements.
- Effective communication and cross-functional collaboration skills.
Education Requirements:
Bachelor’s Degree.
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