TMF Lead II: Drive Trial Master File Excellence (Remote)

Fortrea; United States; Remote; USD 100,000 - 118,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(K)

Paid time off (PTO)

Job summary

A leading clinical research organization is looking for a TMF Lead II to oversee the Trial Master File lifecycle across studies. This role requires extensive experience in clinical research, TMF management, and mentoring while ensuring compliance with regulations. The successful candidate will be responsible for maintaining TMF health, managing documentation, and preparing for audits. The position offers remote work options and competitive benefits, including salary in the range of $100-118K.

Qualifications

• Minimum 7 years’ experience working in a clinical research environment.
• 5+ years experience in TMF.
• Knowledge of regulatory/clinical document requirements.

Responsibilities

• Manage the study TMF throughout its lifecycle.
• Ensure inspection readiness for audits and inspections.
• Provide training to the project team on TMF processes.

Skills

Experience in TMF

Clinical research knowledge

Understanding of GCP and ICH

Process coordination

Education

BS/BA degree in related discipline

MS/MA degree in related discipline

Tools

Microsoft Office

Adobe Acrobat Standard

Job description

A leading clinical research organization is looking for a TMF Lead II to oversee the Trial Master File lifecycle across studies. This role requires extensive experience in clinical research, TMF management, and mentoring while ensuring compliance with regulations. The successful candidate will be responsible for maintaining TMF health, managing documentation, and preparing for audits. The position offers remote work options and competitive benefits, including salary in the range of $100-118K.