ZipRecruiter

Log In

1

Freelance 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 ...

next page

Showing results 1-20

All JobsTrial Master File JobsFreelance Trial Master File JobsFreelance Trial Master File Jobs in Florida

Freelance Trial Master File information

What is a freelance trial master file?

A Freelance Trial Master File (TMF) specialist is an independent professional who manages and maintains the Trial Master File for clinical trials. The TMF is an organized collection of essential documents that demonstrate the compliance of a clinical trial with regulatory requirements and Good Clinical Practice (GCP) guidelines. Freelance TMF specialists typically work on a contract basis with pharmaceutical companies, contract research organizations (CROs), or clinical trial sponsors to ensure that all trial documentation is complete, accurate, and audit-ready.

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

To thrive as a Freelance Trial Master File Specialist, you need a strong understanding of clinical trial documentation, regulatory requirements (such as ICH-GCP), and experience in managing TMF processes. Familiarity with electronic TMF (eTMF) systems, document management tools, and possibly certifications like DIA's TMF Management certificate are typically required. Excellent organizational skills, attention to detail, and effective communication are crucial soft skills for ensuring document accuracy and stakeholder collaboration. These skills are vital for maintaining compliant, audit-ready TMFs that support successful clinical trial execution and regulatory submissions.

What are some common challenges faced by freelance trial master file professionals, and how can they be addressed?

Freelance TMF professionals often encounter challenges such as maintaining document consistency across multiple studies and sponsors, adapting to various electronic TMF (eTMF) systems, and ensuring compliance with evolving regulatory requirements. To address these challenges, it's essential to develop strong organizational skills, stay current with industry regulations like ICH-GCP, and become proficient in commonly used eTMF platforms. Regular communication with sponsors and clinical teams also helps resolve discrepancies quickly and ensures timely document submission.

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 Freelance Trial Master File jobs in Florida?

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

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

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

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

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

Freelance Trial Master File jobs near you

Sr. Clinical Trial Associate

Summit Therapeutics

Miami, FL

$32 - $43.75/hr

Full-time

Posted 4 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

Apply