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Trial Master File Manager Jobs in Delaware (NOW HIRING)

Specialist Study Management

Wilmington, DE · On-site

$33.75 - $45.25/hr

Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File ... Display excellent organization and time management skills, excellent attention to detail, and ...

Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical ... the trial master file (eTMF). Qualifications * Minimum 3 years of experience in Clinical Study ...

Manage the progress of assigned studies by tracking regulatory submissions and approvals ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

CRA 2, Oncology, IQVIA

Wilmington, DE · On-site

$87K - $145K/yr

Manage the progress of assigned studies by tracking regulatory submissions and approvals ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

Paralegal

Wilmington, DE · On-site

$35 - $38/hr

... trial-related reference materials for legal teams. • Maintain orderly records of filings, exhibits, and discovery materials using case management tools and established litigation practices. • ...

All applicants must read the detailed physical requirements for this position which is located at and the file is named Master Electrician - OMB - Division of Facilities Management. Criminal ...

All applicants must read the detailed physical requirements for this position which is located at and the file is named Master Electrician - OMB - Division of Facilities Management. Criminal ...

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Showing results 1-20

Trial Master File Manager information

See Delaware salary details

$44.5K

$75.6K

$114.1K

How much do trial master file manager jobs pay per year?

As of Jul 29, 2026, the average yearly pay for trial master file manager in Delaware is $75,649.00, according to ZipRecruiter salary data. Most workers in this role earn between $55,500.00 and $93,600.00 per year, depending on experience, location, and employer.

What are some common challenges faced by Trial Master File Managers, and how can they be addressed?

Trial Master File Managers often encounter challenges such as ensuring TMF completeness, maintaining regulatory compliance, and coordinating document submissions across multiple stakeholders. Keeping documents up-to-date and audit-ready requires strong attention to detail and effective communication with clinical teams, vendors, and sponsors. Leveraging electronic TMF systems, implementing standardized processes, and promoting regular training can help address these challenges and ensure the integrity of the TMF throughout a study.

What is a Trial Master File Manager?

A Trial Master File Manager is a professional responsible for overseeing the creation, maintenance, and quality control of the Trial Master File (TMF) in clinical research. The TMF is a collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. The manager ensures that all documents are complete, accurate, and compliant with regulatory requirements throughout the trial's lifecycle. They work closely with clinical teams, auditors, and regulatory authorities to guarantee readiness for inspections and audits. Their role is crucial for maintaining transparency and credibility in clinical research processes.

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

To thrive as a Trial Master File Manager, you typically need a strong background in clinical research, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, GCP guidelines, and relevant industry certifications like DIA's TMF Professional Certification is important. Attention to detail, organizational skills, and effective communication help ensure TMF integrity and coordination across cross-functional teams. These skills are crucial for maintaining regulatory compliance, audit readiness, and efficient clinical trial operations.
What are popular job titles related to Trial Master File Manager jobs in Delaware? For Trial Master File Manager jobs in Delaware, the most frequently searched job titles are:
What cities in Delaware are hiring for Trial Master File Manager jobs? Cities in Delaware with the most Trial Master File Manager job openings:

Specialist Study Management

US Tech Solutions

Wilmington, DE • On-site

$33.75 - $45.25/hr

Other

Re-posted 4 days ago


Job description

Company Description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.

Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job Description
  • Bachelor's degree is preferred
  • 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required
  • Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance.
  • Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Client Authoring Guide for Regulatory Documents to support publishing in GEL
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
  • Set-up, populate and accurately maintain information in Client tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems

Skills and Competencies

  • Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
  • Working knowledge of clinical study documents
  • Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
  • Good verbal and written communication
  • Good interpersonal skills and ability to work in an international team environment
  • Willingness and ability to train others on study administration procedures
  • Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
  • Integrity and high ethical standards
Qualifications
  • Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
Additional Information

Sneha Shrivastava

Sr Technical Recruiter

862 - 579 - 4236



US Tech Solutions logo

About US Tech Solutions

Sourced by ZipRecruiter

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Jersey City, NJ, US

Year founded

2000

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