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Director Trial Master File Jobs in Florida (NOW HIRING)

IQVIA

Sr. Clinical Research Associate, IQVIA

Tampa, FL · On-site

$101K - $169K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...

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Director Trial Master File information

What is the difference between Director Trial Master File vs Clinical Trial Coordinator?

AspectDirector Trial Master FileClinical Trial Coordinator
CredentialsAdvanced degrees (e.g., Life Sciences, Healthcare), experience in clinical trial documentationBachelor's degree, certification in clinical research preferred
Work EnvironmentSenior management, overseeing TMF processes across projectsOperational role, supporting trial activities at site or sponsor level
Industry UsageUsed in pharmaceutical, biotech, and CRO settings for document oversightCommonly employed in clinical sites and research organizations

The Director Trial Master File focuses on strategic oversight and management of trial documentation, ensuring compliance and quality. In contrast, the Clinical Trial Coordinator handles day-to-day trial activities, including document collection and site coordination. Both roles are essential but differ in scope, responsibilities, and seniority within the clinical research process.

What are the key skills and qualifications needed to thrive as a director trial master file?

To thrive as a Director Trial Master File, you need deep knowledge of clinical trial processes, regulatory guidelines (such as GCP and ICH), and extensive experience in TMF management, often supported by a relevant degree and prior leadership in clinical operations. Expertise with electronic Trial Master File (eTMF) systems, document management platforms, and familiarity with industry certifications like DIA TMF Practitioner are highly valued. Strong leadership, attention to detail, and excellent communication skills distinguish top performers in this role. These capabilities ensure regulatory compliance, audit readiness, and effective oversight of clinical trial documentation, which are critical for successful drug development.

What are some common challenges a director trial master file faces when ensuring TMF completeness and inspection readiness?

A Director of Trial Master File often encounters challenges related to maintaining TMF completeness across multiple studies and vendors, ensuring timely document submission, and preparing for regulatory inspections. Coordinating efforts among cross-functional teams—including clinical operations, regulatory affairs, and external partners—can be complex, especially when aligning on documentation standards and resolving discrepancies. Proactive communication, robust quality control processes, and familiarity with evolving regulatory requirements are key to overcoming these challenges and ensuring inspection readiness.

What are the roles and responsibilities of a director trial master file?

A Director of Trial Master File (TMF) oversees the management and quality of TMF systems, which are essential for documenting the conduct of clinical trials. They ensure that all trial documentation is complete, accurate, and compliant with regulatory requirements. This role involves developing TMF strategies, leading teams, implementing best practices, and collaborating with clinical, regulatory, and quality assurance departments to support clinical trial audits and inspections. The director also manages TMF vendors, monitors key performance indicators, and drives process improvements.
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:
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Director Trial Master File jobs near you

Clinical Trial Manager, Immunology

SAb Biotherapeutics, Inc

Miami Beach, FL • On-site, Remote

$150K - $165K/yr

Full-time

Posted 22 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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