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Trial Master File Jobs in Florida (NOW HIRING)

U.S. Renal Care

Clinical Research Coordinator

Fort Myers, FL · On-site

$22.75 - $30/hr

Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and ...

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Trial Master File information

What are the key skills and qualifications needed to thrive in the trial master file position, and why are they important?

To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.

What is a trial master file?

A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.

What are the typical responsibilities and daily tasks of a trial master file specialist?

As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.

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 jobs in Florida? For Trial Master File jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Trial Master File jobs in Florida look for? The top searched job categories for Trial Master File jobs in Florida are:
What cities in Florida are hiring for Trial Master File jobs? Cities in Florida with the most Trial Master File job openings:
Trial Master File jobs near you
Infographic showing various Trial Master File job openings in Florida as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 12% Part Time, 1% Temporary, 2% Contract, and 1% Nights. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution.

Clinical Trial Manager, Immunology

SAb Biotherapeutics, Inc

Miami Beach, FL • On-site, Remote

$150K - $165K/yr

Full-time

Posted 25 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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