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Director Trial Master File Jobs in Texas (NOW HIRING)

Winaxis

Clinical Research Coordinator

Dallas, TX · On-site

$24 - $32/hr

Maintain Trial Master File (TMF), Investigator Site File (ISF), and essential study documents. * Report adverse events and serious adverse events according to protocol and regulatory requirements.

Winaxis

Clinical Research Coordinator

Dallas, TX · On-site

$24 - $32/hr

Maintain Trial Master File (TMF), Investigator Site File (ISF), and essential study documents. Report adverse events and serious adverse events according to protocol and regulatory requirements.

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 ...

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 ...

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

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

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

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

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

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 ...

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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 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

Clinical Research Coordinator

Winaxis

Dallas, TX • On-site

$24 - $32/hr

Full-time

Medical, PTO

Re-posted 20 days ago

Job description

Job Title : Clinical Research Coordinator (CRC)

Experience : 0–3 Years

Location : Dallas, Texas

Employment Type : Full-time

Job Summary:-

We are looking for a motivated and detail-oriented Clinical Research Coordinator to support the planning, execution, and management of clinical research studies. The ideal candidate should have 0–3 years of experience in clinical research and a strong understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements. Fresh graduates with relevant internships or clinical research training are encouraged to apply.

Key Responsibilities

  • Coordinate and manage clinical research studies in compliance with study protocols, ICH-GCP guidelines, and applicable regulations.

  • Screen, recruit, and enroll study participants.

  • Obtain informed consent from study participants.

  • Schedule and coordinate patient visits and follow-up appointments.

  • Collect, verify, and maintain accurate study documentation and source data.

  • Enter clinical data into Electronic Data Capture (EDC) systems.

  • Maintain Trial Master File (TMF), Investigator Site File (ISF), and essential study documents.

  • Report adverse events and serious adverse events according to protocol and regulatory requirements.

  • Coordinate with investigators, sponsors, CROs, and ethics committees.

  • Prepare for monitoring visits, audits, and regulatory inspections.

  • Ensure protocol compliance and participant safety throughout the study.

  • Assist with study start-up, close-out activities, and regulatory submissions.

Required Qualifications

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Microbiology, or a related field.

  • 0–3 years of experience in clinical research or clinical trial coordination.

  • Knowledge of ICH-GCP, FDA, and local regulatory guidelines.

  • Familiarity with EDC systems and Microsoft Office.

  • Strong organizational, communication, and documentation skills.

  • Ability to work independently and as part of a multidisciplinary team.

Preferred Qualifications

  • GCP Certification.

  • Clinical Research certification is an added advantage.

  • Experience with site coordination or patient recruitment.

  • Knowledge of clinical trial documentation and regulatory submissions.

Key Skills

  • Clinical Trial Coordination

  • ICH-GCP Compliance

  • Patient Recruitment

  • Informed Consent Process

  • Source Documentation

  • Electronic Data Capture (EDC)

  • Trial Master File (TMF)

  • Regulatory Documentation

  • Adverse Event Reporting

  • Data Management

  • Communication & Coordination

  • Attention to Detail

  • Time Management

Benefits

  • Competitive salary

  • Health insurance

  • Performance-based incentives

  • Training and career development opportunities

  • Paid leave and holidays

  • Exposure to global clinical research projects

How to Apply

Interested candidates can submit their updated resume along with a cover letter highlighting their clinical research experience, certifications, and relevant skills.