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Trial Master File Associate Jobs in Florida (NOW HIRING)

IQVIA

Sr. Clinical Research Associate, IQVIA

Tampa, FL · On-site

$101K - $169K/yr

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

Sr. Clinical Research Associate, IQVIA

Tampa, FL

$101K - $169K/yr

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

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Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

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

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
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 Associate jobs in Florida? For Trial Master File Associate jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Florida look for? The top searched job categories for Trial Master File Associate jobs in Florida are:
What cities in Florida are hiring for Trial Master File Associate jobs? Cities in Florida with the most Trial Master File Associate job openings:
Trial Master File Associate jobs near you
Clinical Trial Manager, Immunology

Clinical Trial Manager, Immunology

SAb Biotherapeutics, Inc

Miami Beach, FL • On-site, Remote

$150K - $165K/yr

Full-time

Posted 12 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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