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Director Trial Master File Jobs in Texas (NOW HIRING)

IQVIA Argentina

CRA 2, Oncology, IQVIA

Fort Worth, TX · On-site

$87.20 - $145.30/hr

Ensure copies or originals are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained per GCP and local regulations. * Create and ...

Immatics NV

Senior Clinical Research Associate

Houston, TX · On-site

$120K - $135K/yr

Associate Director, Team Lead Site Operations Location :FullyRemote Salary Range: $120,000 to $135 ... Maintainaccurateandtimelymonitoring documentation, including trip reports and trial master file ...

Immatics NV

Senior Clinical Research Associate

Houston, TX · On-site

$120K - $135K/yr

Associate Director, Team Lead Site Operations Location :FullyRemote Salary Range: $120,000 to $135 ... Maintainaccurateandtimelymonitoring documentation, including trip reports and trial master file ...

U.S. Renal Care

Clinical Research Coordinator

San Antonio, TX · On-site

$20.75 - $27.50/hr

... of the clinical research is directed by the PI. The CRC will work collaboratively with the ... Trial Master File). This includes those documents that will allow for the evaluation of the ...

Immatics NV

Senior Clinical Research Associate

Houston, TX · On-site

$120K - $135K/yr

Associate Director, Team Lead Site Operations Location : Fully Remote Salary Range: $120,000 to ... Maintain accurate and timely monitoring documentation, including trip reports and trial master file ...

IQVIA

CRA 2, Oncology, IQVIA

Dallas, TX

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

Immatics NV

Senior Clinical Research Associate

Houston, TX · On-site

$120K - $135K/yr

Associate Director, Team Lead Site Operations Location : Fully Remote Salary Range: $120,000 to ... Maintain accurate and timely monitoring documentation, including trip reports and trial master file ...

IQVIA

CRA 2, Oncology, IQVIA

Fort Worth, TX

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

Dallas, TX

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

San Antonio, TX · On-site

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

San Antonio, TX

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

Houston, TX

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

Houston, TX · On-site

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA

CRA 2, Oncology, IQVIA

Fort Worth, TX · On-site

$87K - $145K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

IQVIA Argentina

CRA 2, Oncology, IQVIA

Dallas, TX · On-site

$87.20 - $145.30/hr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

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Director Trial Master File information

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 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 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 most commonly searched types of Trial Master File jobs in Texas?

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

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

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

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

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

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

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

Director Trial Master File jobs near you

CRA 2, Oncology, IQVIA

IQVIA Argentina

Fort Worth, TX • On-site

$87.20 - $145.30/hr

Other

Posted 6 days ago

Job description

QA RA 2 – Clinical Research Associate

Fort Worth, United States of America | Full time | Field-based | R1537618

Essential Functions
  • Perform site monitoring visits (selection, initiation, monitoring, and close‑out) in accordance with contracted scope of work and regulatory requirements (Good Clinical Practice and International Conference on Harmonization guidelines).
  • Work with sites to adapt, drive, and track subject recruitment plans in line with project needs.
  • Administer protocol and study training to assigned sites and maintain regular communication to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices, ensuring proper protocol conduct and regulatory adherence; raise quality issues as appropriate.
  • Track study progress: regulatory submissions, approvals, recruitment, enrollment, case report form completion, and data query generation/resolution. May provide support during the start‑up phase.
  • Ensure copies or originals are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained per GCP and local regulations.
  • Create and maintain documentation for site management, monitoring visit findings, action plans, and other required study documentation.
  • Collaborate with study team members for project execution support as needed.
  • Manage site financial matters in accordance with the clinical trial agreement and retrieve invoices per local requirements where applicable.
Education & Experience
  • Bachelor’s degree (scientific discipline or health care preferred).
  • 1.5 to 2 years of relevant CRA experience, including on‑site monitoring.
Compensation

The potential base pay range for this role, when annualized, is $87,200.00 - $145,300.00. Actual base pay may vary based on qualifications, location, and schedule. Incentive plans, bonuses, and other benefits may be offered.

Equal Opportunity Employer

IQVIA is a proud equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other protected class.

Integrity Statement

IQVIA maintains a zero‑tolerance policy for candidate fraud. All application information and credentials must be truthful and complete. False statements or omissions will result in immediate disqualification or termination as appropriate.

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