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Director Trial Master File Jobs in Florida (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 ...

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 ...

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Director Trial Master File information

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 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 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 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 Director Trial Master File jobs in Florida?

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

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

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

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

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

Director Trial Master File jobs near you

Sr. Clinical Trial Associate

Miami, FL

Summit Therapeutics
See more jobs at Summit Therapeuticsexternal

$32 - $43.75/hr

Full-time

Posted 8 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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