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Trial Master File Associate Jobs in New Jersey (NOW HIRING)

Summit Therapeutics

Sr. Clinical Trial Associate

Princeton, NJ · On-site

$35 - $48/hr

SENIOR CLINICAL TRIAL ASSOCIATE Location: Onsite - Princeton, NJ or Miami, FL Overview of Role: The ... Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems ...

Legend Biotech US

Senior Clinical Trial Associate

Somerset, NJ · Hybrid

$35.50 - $48.25/hr

Legend Biotech is seeking a Senior Clinical Trial Associate as part of the Clinical Operations team ... Trial Master Files (TMFs/eTMFs), and study correspondence. * Ensure documentation is current ...

Winaxis

Clinical Research Coordinator

Jersey City, NJ · On-site

$25.25 - $33.75/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.

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Legend Biotech US

Senior Clinical Trial Associate

Somerset, NJ · On-site

$35.50 - $48.25/hr

Legend Biotech is seeking a Senior Clinical Trial Associate as part of the Clinical Operations team ... Trial Master Files (TMFs/eTMFs), and study correspondence. * Ensure documentation is current ...

Legend Biotech USA, Inc.

$35.50 - $48.25/hr

Legend Biotech is seeking a Senior Clinical Trial Associate as part of the Clinical Operations team ... files, Trial Master Files (TMFs/eTMFs), and study correspondence.Ensure documentation is current ...

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Trial Master File Associate information

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 key skills and qualifications needed to thrive as a Trial Master File Associate?

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 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 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 are the most commonly searched types of Trial Master File jobs in New Jersey?

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

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For Trial Master File Associate jobs in New Jersey, the most frequently searched job titles are:

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What cities in New Jersey are hiring for Trial Master File Associate jobs?

Cities in New Jersey 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 New Jersey as of August 2026, with employment types broken down into 1% As Needed, 69% Full Time, 27% Part Time, 1% Temporary, and 2% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

eTrial Master File Senior Analyst

Intelliswift Software

Lawrenceville, NJ • On-site

$122K - $122K/yr

Full-time

Re-posted 14 days ago

Job description

Job ID: 22-04869 Position: Scientific - eTrial Master File Senior Analyst
Research and Development/Global Clinical Compliance and Continuous Improvement/Global Clinical Documents, Submissions and Disclosure
To deliver technical expertise in the Electronic Trial Master File (eTMF), provide support for all clinical trials throughout the lifecycle of the trial and what is in the book of work, and support inspection readiness goals in compliance with ICH/GCP guidelines. Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF
• Key deliverables include: ensuring accuracy at the document level in the eTMF for all Client-managed studies and CRO-managed studies in the Client eTMF, with the study teams and TMF Study Leads, Global Trial Managers and/or Subject Matter Experts for eTMF
• Monitor the adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles and Client policies as it relates to the completeness and accuracy of the TMF at the document level.
• Ensure that the documents are filed in the correct classification and that the required metadata is accurate and complete in the TMF as per the Study-Specific Master Plan and Master List and are inspection ready at all times.
• Manage complex and more technical tasks within the eTMF; including but not limited to: template creation and management, controlled document templates, system hard deletion process, creating complex ad hoc TMF reports for users, developing custom reports to generate metrics, developing or enhancing macros to streamline existing and new processes.
• Demonstrates ability to make decisions, deliver on commitments, share knowledge, acknowledge others achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
• Exhibit knowledge of critical and essential documents to be able to perform Quality Validation checks on documents that have had completed quality review.
• Ability to make sound business decisions based on evidence (guidance documents and Manual of Operations) and experience regarding the outcome of the eTMF work that is performed that involves critical or complex documents.
• Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection.
• Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines.
• Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
• Provide support to TMF implementation, internal audits and regulatory inspections.
• Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge other's achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.
Minimum of Bachelor's degree in a scientific or related discipline
At least 5 years of TMF experience required, including experience in study start-up, study maintenance and document quality reviews.
Relevant experience in clinical trials related roles (i.e. clinical operations and project management). Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.
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About Intelliswift

Sourced by ZipRecruiter

Intelliswift is consumed with the love for the new. Once a leading staffing company, Intelliswift now possesses the expertise to build data-rich modern platforms, and to create sophisticated systems for data management and analytics for thinking and connected enterprises. We are a global leader in delivering Digital Product Engineering, Data Management & Analytics, Cloud, Digital Enterprise and MSP/VMS staffing solutions. Led by a team of highly passionate and techno-centric innovators, we consciously embed the spirit of loving and embracing everything new in what we do. We ardently believe that companies that Love the New are at an advantage of being ahead of the curve in this age of digital.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Newark, CA, US

Year founded

2001

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