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Trial Master File Jobs in Miami, FL (NOW HIRING)

Summit Therapeutics

Sr. Clinical Trial Associate

Miami, FL

$32 - $43.75/hr

Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF) required Strong understanding of the phases of clinical drug development and clinical operation ...

SAB

Clinical Trial Manager, Immunology

Miami Beach, FL · Remote

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 ...

Summit Therapeutics

Sr. Clinical Trial Associate

Miami, FL · On-site

$32 - $43.75/hr

Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF) required • Strong understanding of the phases of clinical drug development and clinical ...

Konare Law

Immigration Paralegal

Coral Gables, FL · On-site

$25/hr

You'll manage casework, keep clients informed, and help prepare legal filings and trial materials ... LexisNexis, AILA Library, Practice Law Institute (PLI), Law360, Best Practice, Master Series, PLI ...

Konare Law

Immigration Paralegal

Coral Gables, FL · On-site

$25/hr

You'll manage casework, keep clients informed, and help prepare legal filings and trial materials ... LexisNexis, AILA Library, Practice Law Institute (PLI), Law360, Best Practice, Master Series, PLI ...

Konare Law

Immigration Paralegal

Coral Gables, FL · On-site

$25/hr

You'll manage casework, keep clients informed, and help prepare legal filings and trial materials ... LexisNexis, AILA Library, Practice Law Institute (PLI), Law360, Best Practice, Master Series, PLI ...

Danaher

Principal Clinical Scientist

Miami, FL · On-site +1

This role is responsible for clinical trial strategies within the US and EU regions for Danaher ... Author and review clinical and regulatory documentation-including study reports, technical files ...

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Trial Master File information

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 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 are the most commonly searched types of Trial Master File jobs in Miami, FL?

The most popular types of Trial Master File jobs in Miami, FL are:

What are popular job titles related to Trial Master File jobs in Miami, FL?

For Trial Master File jobs in Miami, FL, the most frequently searched job titles are:

What job categories do people searching Trial Master File jobs in Miami, FL look for?

The top searched job categories for Trial Master File jobs in Miami, FL are:

What cities near Miami, FL are hiring for Trial Master File jobs?

Cities near Miami, FL with the most Trial Master File job openings:

Trial Master File jobs near you
Infographic showing various Trial Master File job openings in Miami, FL as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Sr. Clinical Trial Associate

Miami, FL

Summit Therapeutics
See more jobs at Summit Therapeuticsexternal

$32 - $43.75/hr

Full-time

Posted 9 days ago

Job description

 SENIOR CLINICAL TRIAL ASSOCIATE

Location: ONSITE - Miami, FL

Overview of Role:

The Senior Clinical Trial Associate (Senior CTA) is an experienced clinical operations professional who is responsible for supporting the daily workflow of clinical operations activities. They will provide robust administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.

Role and Responsibilities:

  • Provides comprehensive administrative support to the clinical operations study team,including managing meeting logistics, creating agendas, and drafting meeting minutes, withminimal oversite
  • Executes tasks as assigned by the Clinical Operations Manager, including study budgetforecasting and tracking
  • Ensures accurate and timely documentation, including eTMF management, study contractsand financial records in compliance with ICH-GCP, company policies and regulatoryrequirements
  • Coordinates clinical operations activities across cross-functional teams, including contractmanagement, vendor oversight, site start-up and activation, protocol deviation
  • Creates and maintains study-related materials, such as country and site binders and trackstrial milestones
  • Ensure the eTMF is being maintained up-to-date and all essential documents areappropriately filed in the eTMF
  • Collaborates with CROs to ensure accurate data collection and entry into the CTMS andEDC
  • Attend and contribute to team meetings, taking detailed meeting minutes
  • Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors
  • Actively participates in process improvement initiatives to enhance clinical operations efficiency
  • All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

  • Bachelor's degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience required 4+ years of experience in clinical study environment within CRO or Pharmaceutical company
  • Experience using Clinical Trial Management Systems (CTMS) and Clinical Trial Master File Systems (eTMF) required Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out
  • Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
  • Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
  • Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.
  • Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
  • Attention to detail, accuracy and confidentiality

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