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Director Trial Master File Jobs in Missouri (NOW HIRING)

Jobgether

$25.75 - $35.25/hr

You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations. The position combines document ...

IQVIA

CRA 2, Oncology, IQVIA

Kansas City, MO · 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

Kansas City, MO · 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 1, IQVIA Biotech

Kansas City, MO · On-site

$71K - $145K/yr

During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...

IQVIA

CRA 1, IQVIA Biotech

Kansas City, MO

$71K - $145K/yr

During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...

kindeva

Document Coordinator I

Maryland Heights, MO · On-site

... SOPs, master batch records, specifications, laboratory methods, protocols, Design History File ... trial, experimental, and research batch records in accordance with production schedules and ...

kindeva

Document Coordinator I

Maryland Heights, MO

... SOPs, master batch records, specifications, laboratory methods, protocols, Design History File ... trial, experimental, and research batch records in accordance with production schedules and ...

kindeva

Document Coordinator I

Maryland Heights, MO

... SOPs, master batch records, specifications, laboratory methods, protocols, Design History File ... trial, experimental, and research batch records in accordance with production schedules and ...

kindeva

Document Coordinator I

Maryland Heights, MO · On-site

... SOPs, master batch records, specifications, laboratory methods, protocols, Design History File ... trial, experimental, and research batch records in accordance with production schedules and ...

Polsinelli

Practice Group Assistant

Kansas City, MO · On-site

Strong knowledge of court rules; docketing and filing with courts * Conduct various document ... Relativity, CaseMap, Trial Director REQUIREMENTS * Paralegal Certificate and bachelor's degree ...

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All JobsTrial Master File JobsDirector Trial Master File JobsDirector Trial Master File Jobs in Missouri

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 Missouri?

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

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

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

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

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

Director Trial Master File jobs near you

Associate II, TMF Operations

Jobgether

On-site

$25.75 - $35.25/hr

Full-time

Posted 14 days ago

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate II, TMF Operations based in Netherlands.

This role supports the accurate and compliant management of essential clinical trial documentation within a global Clinical Research Organization (CRO) environment.
You will help ensure Trial Master File (TMF) records are processed, reviewed, maintained, and archived according to established procedures and regulatory expectations.
The position combines document quality control, records management, and collaboration with international clinical project teams.
You will contribute directly to data integrity and inspection readiness across complex studies and sponsor portfolios.
The role offers exposure to electronic TMF and document management systems while developing your understanding of clinical research operations.
Success requires strong attention to detail, organization, and the ability to manage multiple deadline-driven activities with accuracy.
It is an excellent opportunity for an early-career professional seeking to build expertise in clinical documentation and TMF operations.

Accountabilities
  • Perform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices.
  • Process, review, classify, and resolve rejected Trial Master File documents across complex clinical studies and sponsor portfolios.
  • Manage essential documents in both electronic and hard-copy formats while maintaining accurate records and consistent document standards.
  • Prepare periodic TMF Quality Control checklists and coordinate their review with relevant project team members.
  • Conduct periodic TMF quality control activities to verify compliance with regulatory requirements, ICH GCP principles, sponsor expectations, SOPs, and industry best practices.
  • Work with electronic document management repositories and eTMF systems to review, index, process, and maintain essential clinical trial documentation.
  • Apply standardized document naming conventions and indexing requirements to ensure records are complete, accurate, searchable, and inspection-ready.
  • Collaborate regularly with project teams and colleagues across functions and geographies to resolve documentation issues and support efficient TMF processes.
  • Maintain high standards of accuracy while managing multiple detailed activities within established timelines.
Requirements:
  • University degree preferred, ideally in Life Sciences or a related discipline.
  • Up to 1-2 years of relevant experience in TMF operations, records management, clinical research, CRO, pharmaceutical, or a related environment.
  • General understanding of clinical research principles, clinical trial processes, and the purpose of Trial Master Files.
  • Experience or demonstrated ability in data collection, indexing, document editing, and applying standardized naming conventions.
  • Ability to work effectively with electronic document repositories, eTMF platforms, or similar document management systems, with willingness to develop further technical proficiency.
  • Strong written and verbal communication skills, with the ability to present information clearly, accurately, and concisely.
  • Exceptional attention to detail and accuracy when handling highly structured and sensitive documentation.
  • Strong planning, prioritization, and organizational skills, with the ability to manage multiple tasks in a deadline-driven environment.
  • Proficiency with Microsoft Word and Excel.
  • Strong interpersonal and collaboration skills, with the ability to work effectively in a fast-paced, changing, and globally distributed environment.
  • A proactive, reliable, and quality-focused approach to work, with a commitment to following procedures and maintaining compliance.
Benefits:
  • Opportunity to build specialized experience in TMF operations and clinical research within a global CRO environment.
  • Exposure to international clinical studies, sponsor portfolios, project teams, and industry best practices.
  • Hands-on experience with electronic TMF and document management technologies.
  • Opportunities to collaborate with experienced professionals across clinical research and project teams.
  • A supportive and inclusive working environment that values collaboration, creativity, and professional development.
  • Career development opportunities within a global organization focused on improving clinical research and patient outcomes.
  • An environment committed to equal opportunity, diversity, inclusion, and respectful collaboration.
  • Meaningful work contributing to the quality, compliance, and integrity of clinical trials that can ultimately improve patients' lives.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
 Why Apply Through Jobgether? 
 
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
 
 
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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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