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Trial Master File Associate Jobs in Missouri (NOW HIRING)

Jobgether

This role offers the opportunity to lead critical Trial Master File operations within a global clinical research environment. You will ensure inspection readiness, compliance, and high-quality ...

IQVIA

CRA 2, Oncology, IQVIA

Kansas City, MO

$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

$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

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Kansas City, MO · On-site

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

Credgeco

Associate Attorney

Kansas City, MO · Hybrid

Represent clients in court, including motion hearings, pre-trial conferences, and trials. * Engage ... Maintain and update client files, ensuring all case documents are properly organized and accessible.

Vensure Employer Services

Be Seen First

Personal Injury Associate

Saint Louis, MO · On-site

$99K - $100K/yr

... filings. * Take and defend depositions of parties, witnesses, treating physicians, and experts ... Prepare cases for mediation, arbitration, and trial. * Serve as first‐ or second‐chair at jury ...

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Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

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

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
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 are popular job titles related to Trial Master File Associate jobs in Missouri? For Trial Master File Associate jobs in Missouri, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Missouri look for? The top searched job categories for Trial Master File Associate jobs in Missouri are:
What cities in Missouri are hiring for Trial Master File Associate jobs? Cities in Missouri with the most Trial Master File Associate job openings:
Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in Missouri as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

TMF Team Lead

Jobgether

On-site, Remote

Other

Posted 5 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 TMF Team Lead based in Netherlands.

This role offers the opportunity to lead critical Trial Master File operations within a global clinical research environment.
You will ensure inspection readiness, compliance, and high-quality document management across multiple clinical studies.
The position combines operational leadership, quality oversight, and collaboration with international project teams and stakeholders.
You will play a key role in maintaining regulatory standards while improving processes and supporting successful clinical trial delivery.
Working with multidisciplinary teams, you will use data-driven insights and strong organizational skills to manage complex documentation activities.
This is an impactful opportunity for a detail-oriented professional who wants to contribute to advancing healthcare and improving patient outcomes.

Accountabilities:

The TMF Team Lead will oversee Trial Master File operations, ensuring compliance with regulatory requirements, internal procedures, and industry best practices. This role requires strong leadership, analytical thinking, and the ability to collaborate with global teams to maintain document quality and inspection readiness.

  • Lead and support the delivery of TMF services across multiple clinical studies.
  • Ensure Trial Master Files remain inspection-ready and compliant with applicable regulations, procedures, and ALCOA principles.
  • Perform Records Management Compliance (RMC) oversight activities and monitor documentation quality.
  • Track key performance indicators and communicate performance insights to project teams and external stakeholders.
  • Identify operational risks, develop mitigation strategies, and support continuous improvement initiatives.
  • Analyze TMF data and apply insights to drive informed, data-based decisions.
  • Develop and maintain project-specific Quality Management Documents.
  • Provide guidance and expertise on TMF-related topics to project team members.
  • Mentor, support, and develop team members while promoting a collaborative working environment.
  • Collaborate with internal teams, sponsors, external partners, and quality assurance stakeholders.
Requirements:

The ideal candidate has experience in clinical research operations, strong knowledge of regulatory requirements, and the ability to manage complex documentation processes in a highly regulated environment. You should be analytical, organized, and comfortable leading teams while working with global stakeholders.

  • University degree preferred, ideally in Life Sciences or a related field.
  • 3-5 years of relevant experience combining education and professional background.
  • Strong understanding of ICH Good Clinical Practice (GCP) guidelines.
  • Experience supporting regulatory inspections, including FDA, PMDA, EMA, BfArM, MHRA, or similar authorities.
  • Hands-on experience with document management systems and/or electronic Trial Master File (eTMF) solutions such as Veeva, Trial Interactive, or Documentum.
  • Experience working within regulated industries, preferably clinical research or pharmaceuticals.
  • Strong analytical skills with the ability to evaluate complex situations using multiple sources of information.
  • Excellent interpersonal and communication skills in a fast-paced, changing environment.
  • Ability to manage multiple priorities while maintaining accuracy and attention to detail.
  • Experience mentoring, training, or managing team members is highly valued.
Benefits:
  • Opportunity to contribute to meaningful healthcare projects that improve patient outcomes.
  • Global and collaborative work environment with multidisciplinary teams.
  • Remote work flexibility.
  • Supportive culture focused on inclusion, collaboration, and professional growth.
  • Career development opportunities and access to learning resources.
  • Exposure to international clinical research projects and industry-leading practices.
  • Opportunity to work with experienced professionals across global teams.
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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