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Trial Master File Manager Jobs in Chicago, IL (NOW HIRING)

IQVIA

CRA 2, Oncology, IQVIA

Chicago, IL

$87K - $145K/yr

Manage the progress of assigned studies by tracking regulatory submissions and approvals ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

CRA 2, Oncology, IQVIA

Chicago, IL

$87K - $145K/yr

Manage the progress of assigned studies by tracking regulatory submissions and approvals ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

Tempus

Sr. Manager, Quality Assurance

Chicago, IL · On-site

Directly conduct audits, including Internal, Investigator Site, and Trial Master File (TMF) audits ... Manage and drive the clinical CAPA and non-conformance programs, ensuring timely root cause ...

Tempus

Sr. Manager, Quality Assurance

Chicago, IL · On-site

Directly conduct audits, including Internal, Investigator Site, and Trial Master File (TMF) audits ... Manage and drive the clinical CAPA and non-conformance programs, ensuring timely root cause ...

Tempus

Director, (GCP) Quality Assurance

Chicago, IL · On-site +1

Conduct audits, including Internal, Investigator Site and Trial Master File. * Host and support ... Provide Executive Management trends and metrics of the clinical QA program and CAPA status, at a ...

New

IQVIA

CRA 1, IQVIA Biotech

Rosemont, IL

$71K - $145K/yr

... site management activities. In this position, you will ensure that assigned study sites conduct ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Rosemont, IL · On-site

$71K - $145K/yr

... site management activities. In this position, you will ensure that assigned study sites conduct ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

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All JobsTrial Master File JobsTrial Master File Manager JobsTrial Master File Manager Jobs in Chicago, IL

Trial Master File Manager information

See Chicago, IL salary details

$45.8K

$77.8K

$117.4K

How much do trial master file manager jobs pay per year?

As of Aug 8, 2026, the average yearly pay for trial master file manager in Chicago, IL is $77,845.00, according to ZipRecruiter salary data. Most workers in this role earn between $57,200.00 and $96,300.00 per year, depending on experience, location, and employer.

What are some common challenges faced by trial master file managers, and how can they be addressed?

Trial Master File Managers often encounter challenges such as ensuring TMF completeness, maintaining regulatory compliance, and coordinating document submissions across multiple stakeholders. Keeping documents up-to-date and audit-ready requires strong attention to detail and effective communication with clinical teams, vendors, and sponsors. Leveraging electronic TMF systems, implementing standardized processes, and promoting regular training can help address these challenges and ensure the integrity of the TMF throughout a study.

What is a trial master file manager?

A Trial Master File Manager is a professional responsible for overseeing the creation, maintenance, and quality control of the Trial Master File (TMF) in clinical research. The TMF is a collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. The manager ensures that all documents are complete, accurate, and compliant with regulatory requirements throughout the trial's lifecycle. They work closely with clinical teams, auditors, and regulatory authorities to guarantee readiness for inspections and audits. Their role is crucial for maintaining transparency and credibility in clinical research processes.

What are the key skills and qualifications needed to thrive as a trial master file manager?

To thrive as a Trial Master File Manager, you typically need a strong background in clinical research, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, GCP guidelines, and relevant industry certifications like DIA's TMF Professional Certification is important. Attention to detail, organizational skills, and effective communication help ensure TMF integrity and coordination across cross-functional teams. These skills are crucial for maintaining regulatory compliance, audit readiness, and efficient clinical trial operations.
What are the most commonly searched types of Trial Master File jobs in Chicago, IL? The most popular types of Trial Master File jobs in Chicago, IL are:
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Trial Master File Manager jobs near you
Infographic showing various Trial Master File Manager job openings in Chicago, IL as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $77,845 per year, or $37.4 per hour.

Senior Manager, Companion Diagnostics (CDx)

Tempus

Chicago, IL • On-site

$120K - $165K/yr

Full-time

Re-posted 7 days ago

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Senior Manager, Companion Diagnostics (CDx)

Tempus is seeking a Sr. Manager, Companion Diagnostics to lead the planning, oversight, and execution of complex Companion Diagnostic (CDx) clinical validation studies for our pharmaceutical partners. This is a critical, long-term resource needed to establish consistent, internal expertise for high-stakes CDx projects. This role will bridge the gap between drug trial requirements and diagnostic validation, ensuring regulatory compliance and timely study completion.

Key Responsibilities

  • Early Scoping & Alignment: Lead the initial scoping and planning of CDx validation projects and contracts, ensuring input from key internal experts, including Tempus Pharma sequencing, QA, CRO, and Regulatory, external IVD consultants, the drug trial sponsor, and others.
  • Protocol and Strategy Development: Lead the development of diagnostic protocols, including translating drug trial strategy into clinical Dx validation strategy, ensuring sound biostatistical approaches, and alignment on clinical data generation & analysis plans.
  • Cross-Functional Collaboration: Work in partnership with Tempus Pharma sequencing, QA, CRO, and Regulatory, external IVD consultants, the drug trial sponsor, and others to provide necessary input and oversight for both internal and external validation work.
  • Study Execution Oversight: Take ownership of the day-to-day management and execution of regulatory-grade CDx clinical studies for major partners.
  • Regulatory & Quality Compliance: Ensure all clinical validation activities meet the requirements for running clinical device studies, including adherence to GCP and regulatory scrutiny.
  • Project Management: Manage project deliveries, ensuring timely completion and appropriate resourcing to meet agreed-upon timelines.

Qualifications

  • A Ph.D. or Masters in a relevant discipline is highly preferred, though equivalent professional experience will be considered.
  • 5 years of demonstrated experience in IVD or medical device development with a minimum of 2 years of experience in clinical study design and execution.
  • Experience with GCP-grade study setup, monitoring, and reporting, including understanding of trial master file documentation and FDA strategies.
  • Proven ability to understand biostatistics strategy and help craft strategic workplans and Statistical Analysis Plans (SAPs) with support from SMEs (biostatistics, IVD consultants) as needed.
  • Familiarity with the distinct requirements and complexities of CDx clinical development, including clinical validation strategies and ensuring that studies are conducted and documented in accordance with good clinical practices and other applicable regulatory requirements.
  • Ability to facilitate clear communication and coordinate resources across internal (Pharma sequencing, QA, CRO, Regulatory, others) and external (IVD consultants, the drug trial sponsor).

$120,000-$165,000

The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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