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Trial Master File Manager Jobs in Florida (NOW HIRING)

ARTHREX

Clinical Study Manager

Naples, FL

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality ...

Arthrex

Clinical Study Manager

Naples, FL · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Ensures compliance with the Clinical Trial Management System (CTMS), Electronic Trial Master (eTMF) filing, and Electronic Data Capture (EDC) systems, securing essential documents and quality ...

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All JobsTrial Master File JobsTrial Master File Manager JobsTrial Master File Manager Jobs in Florida

Trial Master File Manager information

See Florida salary details

$33.3K

$56.5K

$85.2K

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

As of Aug 14, 2026, the average yearly pay for trial master file manager in Florida is $56,483.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,500.00 and $69,900.00 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?

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 the most commonly searched types of Trial Master File jobs in Florida?

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

What are popular job titles related to Trial Master File Manager jobs in Florida?

For Trial Master File Manager jobs in Florida, the most frequently searched job titles are:

What job categories do people searching Trial Master File Manager jobs in Florida look for?

The top searched job categories for Trial Master File Manager jobs in Florida are:

What cities in Florida are hiring for Trial Master File Manager jobs?

Cities in Florida with the most Trial Master File Manager job openings:

Trial Master File Manager jobs near you

Clinical Trial Manager, Immunology

SAb Biotherapeutics, Inc

Miami Beach, FL • On-site, Remote

$150K - $165K/yr

Full-time

Posted 29 days ago

Job description

The Clinical Trial Manager (CTM) oversees the planning, implementation and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory guidelines. The CTM plays a critical role in coordinating cross functional teams, maintaining budgets, timelines, and quality standards, and ensuring the successful execution of clinical studies.
Duties and Responsibilities (Responsibilities include but are not limited to):
Study Planning and Execution:
  • Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development.
  • Contributing to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as require
  • Oversee implementation and maintenance of Trial Master File for inspection readiness
Project Management:
  • Manage all aspects of clinical trial operations, ensuring adherence to timelines, budgets, and regulatory requirements.
  • Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
  • Manage external vendors with oversight of activities
  • Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations
Team Leadership:
  • Collaborate with cross-functional teams including clinical research associates, data managers, and regulatory affairs to ensure successful trial execution.
Site Management:
  • Establish and maintain strong relationships with clinical trial sites. Provide ongoing support and oversight to ensure compliance with protocol and regulatory standards.
Data Integrity and Compliance:
  • Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines.
Risk Management:
  • Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes.
Communication:
  • Prepare and present updates to stakeholders, including internal teams and external partners. Facilitate regular meetings to discuss study progress and address challenges.
Requirements:
  • B.S. degree with minimum 6-8+ years of experience managing clinical trials in biotech, pharmaceutical
  • Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience
  • Experience with phase II, III study oversight and management
  • Experience with timeline management
  • Strong leadership, effective decision making, and problem-solving skills required
  • Document reviews in relevant systems with a focus on inspection readiness
  • Working knowledge of relevant GCPs and FDA, EMA and MHRA regulations
  • Demonstrated experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems. Experience with operational financial tracking systems a plus
  • Demonstrated proficiency using MS Office applications, including MS Word, Excel, PowerPoint
  • Experience using Smartsheet
  • Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
  • Excellent written and verbal communication skills
Working Environment and Travel:
Generally accepted office working conditions
Travel up to 25% - ability to travel domestically and internationally
Prefer candidates located in Central or Eastern Time Zones
Physical Requirements:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use a computer for extended periods at any given time. The employee must regularly lift and/or move up to 10 pounds.
ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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