Eliassen GroupRemote
eTMF Specialist / Clinical Trial Management Associate
Remote or Almont, Colorado
Contract
2 days ago
Key skills
AIArtificial IntelligenceGoogle CloudVaultCommunicationCollaboration
About this role
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 -46
Responsibilities:
Experience Requirements:
Education Requirements:
Bachelor's Degree.
Recruitment Transparency Notice
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 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 .
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 communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
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 -46
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 Google Cloud Platform and regulatory compliance requirements.
- Effective communication and cross-functional collaboration skills.
Education Requirements:
Bachelor's Degree.
Recruitment Transparency Notice
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 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 .
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 communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!