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Director Trial Master File Jobs in Utah (NOW HIRING)

IQVIA

Clinical Research Associate

Salt Lake City, UT · On-site

$71K - $189K/yr

Ensure essential study documentation is complete, accurate, and maintained within the Trial Master File (TMF) and Investigator Site File (ISF). * Prepare comprehensive monitoring reports, follow-up ...

City of Salt Lake City

Paralegal

Salt Lake City, UT · On-site

$30.74 - $41.97/hr

Paralegal Works for the City Attorney or City Prosecutor and, as assigned under the direct ... Prepares all trial folders and notebooks for use by the supervising attorney in case presentations ...

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Director Trial Master File information

What are the roles and responsibilities of a director trial master file?

A Director of Trial Master File (TMF) oversees the management and quality of TMF systems, which are essential for documenting the conduct of clinical trials. They ensure that all trial documentation is complete, accurate, and compliant with regulatory requirements. This role involves developing TMF strategies, leading teams, implementing best practices, and collaborating with clinical, regulatory, and quality assurance departments to support clinical trial audits and inspections. The director also manages TMF vendors, monitors key performance indicators, and drives process improvements.

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

To thrive as a Director Trial Master File, you need deep knowledge of clinical trial processes, regulatory guidelines (such as GCP and ICH), and extensive experience in TMF management, often supported by a relevant degree and prior leadership in clinical operations. Expertise with electronic Trial Master File (eTMF) systems, document management platforms, and familiarity with industry certifications like DIA TMF Practitioner are highly valued. Strong leadership, attention to detail, and excellent communication skills distinguish top performers in this role. These capabilities ensure regulatory compliance, audit readiness, and effective oversight of clinical trial documentation, which are critical for successful drug development.

What are some common challenges a director trial master file faces when ensuring TMF completeness and inspection readiness?

A Director of Trial Master File often encounters challenges related to maintaining TMF completeness across multiple studies and vendors, ensuring timely document submission, and preparing for regulatory inspections. Coordinating efforts among cross-functional teams—including clinical operations, regulatory affairs, and external partners—can be complex, especially when aligning on documentation standards and resolving discrepancies. Proactive communication, robust quality control processes, and familiarity with evolving regulatory requirements are key to overcoming these challenges and ensuring inspection readiness.

What is the difference between Director Trial Master File vs Clinical Trial Coordinator?

AspectDirector Trial Master FileClinical Trial Coordinator
CredentialsAdvanced degrees (e.g., Life Sciences, Healthcare), experience in clinical trial documentationBachelor's degree, certification in clinical research preferred
Work EnvironmentSenior management, overseeing TMF processes across projectsOperational role, supporting trial activities at site or sponsor level
Industry UsageUsed in pharmaceutical, biotech, and CRO settings for document oversightCommonly employed in clinical sites and research organizations

The Director Trial Master File focuses on strategic oversight and management of trial documentation, ensuring compliance and quality. In contrast, the Clinical Trial Coordinator handles day-to-day trial activities, including document collection and site coordination. Both roles are essential but differ in scope, responsibilities, and seniority within the clinical research process.

What are the most commonly searched types of Trial Master File jobs in Utah?

The most popular types of Trial Master File jobs in Utah are:

What are popular job titles related to Director Trial Master File jobs in Utah?

For Director Trial Master File jobs in Utah, the most frequently searched job titles are:

What job categories do people searching Director Trial Master File jobs in Utah look for?

The top searched job categories for Director Trial Master File jobs in Utah are:

What cities in Utah are hiring for Director Trial Master File jobs?

Cities in Utah with the most Director Trial Master File job openings:

Director Trial Master File jobs near you

Clinical Operations Associate

BioFire Defense

Salt Lake City, UT • On-site

$27/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 3 days ago

New

Job description

At BioFire Defense, our workplace is as vibrant as our mission: casual vibes, intense execution, and a passion for IMPACT.
Position Summary
The Clinical Operations Associate supports the execution of clinical studies by ensuring compliance with company policies, BioFire Defense's Quality Management System, Good Clinical Practices, and applicable regulatory standards, while assisting with SOP/WID updates and regulatory guidance reviews. This role assists Clinical Affairs group with study logistics, including supply management, shipment coordination/execution, budget support, maintaining the electronic Trial Master File, as well as data verification and monitoring activities. They will assist the team with Biosafety Level 2 laboratory work such as managing clinical specimen inventory and in-house clinical studies while adhering to safety protocols and accurate documentation practices. The position involves routine problem-solving within established procedures, cross-functional collaboration, occasional communication with clinical sites, and additional administrative responsibilities as assigned. The Clinical Operations Associate exhibits strong communication, organization, and attention to detail.
Primary Duties
Compliance and Quality: Perform all work in compliance with company policies and BioFire Defense's Quality Management System. Support Quality compliance by formatting, revising, and editing relevant SOPs/WIDs. Support Regulatory compliance by reviewing and summarizing relevant regulatory guidance and standards. Draft study documents in compliance with Good Clinical Practices (GCP).
Clinical Study Support: Assist Clinical Affairs group with daily operations of clinical studies and contribute to ongoing monitoring activities. Prepare study supplies for clinical sites and coordinate clinical study shipments to and from clinical sites. Support management of the electronic Trial Master File (eTMF) and other internal tracking documents.
Data Management: Support Clinical Affairs group with data management activities including data verification for clinical and regulatory studies, review of electronic case report forms and run files. Support development, maintenance, and/or validation of data management tools (R, Python, Microsoft Products).
Specimen Management: Work in a Biosafety Level 2 environment with potentially pathogenic microbes, clinical specimens, and body fluids. Support maintenance of the clinical specimen inventory through internal spreadsheets and Laboratory Information Management System (LIMS).
Qualifications
Training, Education, and Experience:
  • Bachelor's degree in scientific discipline.
  • 1-2 years' of project or clinical study coordination, or other related experience, preferred.

Skills:
  • Strong written and verbal communication skills with an emphasis in technical writing.
  • Ability to work effectively with multiple disciplines and personalities.
  • Self-starter, with the ability to work and learn independently.
  • Attention to detail is fundamental to this position.
  • Ability to accurately follow written and verbal instructions.
  • Basic knowledge of Microsoft Excel and Word.
  • Strong organizational, time management, and administrative skills.

Physical Requirements and Role-Based Expectations:
  • Must be comfortable working with Biosafety Level 2 pathogens.
  • Must be comfortable working with human specimens and bodily fluids (blood, saliva, sputum, etc.).
  • Manual and visual dexterity to handle small tubes and manipulate very small volumes; reasonable accommodations are applicable.
  • Must be able to wear personal protective equipment, including disposable gloves, facemask, and safety glasses, as needed.
  • Must be comfortable working with cleaning products such as bleach.
  • Must maintain regular and consistent on-site attendance.
  • Must be able to safely lift and maneuver 40lbs.

Compensation will be determined based on the candidate's experience, skills, and qualifications.
Benefits:
Medical
Dental
Vision
Bonus eligible
9/8/80 work schedule (every other Friday off)
401k - company match of 5% regardless of participation and up to a total of 9.5% company match if contributing
160 Hours of PTO (prorated from date of hire)
9 Paid Holidays
Paid Winter Break from the work week between December 24 thru December 31
Participation in Company's Wellness Program (discounted medical premiums)
Multiple Company Sponsored Events Each Year (catered breakfast/lunch, holiday parties, snacks)
Convenient location near I-15 and Trax Station
Free Parking
Our EEO Policy
BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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