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Tmf Manager Jobs in Colorado (NOW HIRING)

Manage site essential document collection and TMF reconciliation with site files * Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals

Senior Clinical Research Associate

Denver, CO · On-site +1

$110K - $138K/yr

Manage site essential document collection and TMF reconciliation with site files * Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals

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Tmf Manager information

See Colorado salary details

$30

$65

$101

How much do tmf manager jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for tmf manager in Colorado is $65.74, according to ZipRecruiter salary data. Most workers in this role earn between $53.32 and $74.04 per hour, depending on experience, location, and employer.

What is a TMF Manager?

A TMF (Trial Master File) Manager is responsible for overseeing the management, maintenance, and compliance of clinical trial documentation. They ensure that the TMF is accurate, complete, and inspection-ready in accordance with regulatory requirements, such as ICH-GCP and FDA guidelines. TMF Managers collaborate with clinical teams, quality assurance, and regulatory authorities to support audit and inspection activities. Their role is critical in ensuring data integrity and regulatory compliance throughout the clinical trial lifecycle.

What are the key skills and qualifications needed to thrive as a TMF Manager?

To excel as a TMF Manager (Trial Master File Manager), you need a solid understanding of clinical trial documentation, GCP (Good Clinical Practice) guidelines, and regulatory requirements—typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and relevant industry certifications such as RAC or DIA TMF certificates is important. Exceptional attention to detail, organizational skills, and the ability to communicate effectively across cross-functional teams distinguish top TMF Managers. These competencies are essential for ensuring the integrity, completeness, and audit-readiness of clinical trial documentation throughout the study lifecycle.

What are some typical challenges a TMF Manager might face in their role?

TMF Managers often encounter challenges such as ensuring consistent TMF document quality across multiple studies, meeting tight regulatory submission deadlines, and facilitating communication among global project teams. Keeping the TMF up to date and audit-ready requires strong organizational skills and proactive problem-solving, as studies can involve large volumes of documentation and frequent protocol amendments. Effective TMF Managers routinely collaborate with clinical, regulatory, and quality assurance teams to ensure document accuracy and regulatory compliance. Overcoming these challenges is key to maintaining smooth clinical trial operations and supporting successful regulatory inspections.

What cities in Colorado are hiring for Tmf Manager jobs?

Cities in Colorado with the most Tmf Manager job openings:

Infographic showing various Tmf Manager job openings in Colorado as of August 2026, with employment types broken down into 86% Full Time, 12% Part Time, and 2% Contract. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution, with an average salary of $136,733 per year, or $65.7 per hour.

eTMF Specialist, Pharma, BiAnnual Review Project

Almont, CO • On-site

Eliassen Group
IT Services • 5 - 10K employees

$65 - $75/hr

Other

Medical, Dental, Vision, Life, Retirement

Posted 16 days ago


Job description

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.

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-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.

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!

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About Eliassen Group

Sourced by ZipRecruiter

Eliassen Group provides strategic consulting and talent solutions to drive our clients' innovation and business results. Our purpose is to positively impact the lives of our employees, clients, consultants, and the communities in which we operate. Leveraging over 30 years of success, our expertise in talent solutions, life sciences consulting, Agile consulting, cloud services, risk management, business optimization, and managed services enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA, and with offices from coast to coast, Eliassen Group offers local community presence and deep networks, as well as national reach.

Industry

It services

Company size

5,001 - 10,000 Employees

Headquarters location

Reading, MA, US

Year founded

1989