Remote TMF Lead II for LATAM Trials

Precision Medicine Group; United States; Remote; USD 95,000 - 130,000; Full time

Job summary

Precision Medicine Group is expanding across LATAM and seeks an experienced Trial Master File Lead II to establish a regional TMF function. You will support project teams in maintaining compliant TMFs per GCP, SOPs, and company standards, across multiple studies.

The role emphasizes leading TMF planning, document indexing, and timely archival, with involvement in audits and risk mitigation. Fluency in English and a Bachelor’s degree are required.

Qualifications

• Bachelor’s degree or international equivalent; 3+ years experience in TMF or related role.
• Professional working proficiency in English.
• Experience with FDA/ICH-GCP regulations.

Responsibilities

• Maintain high-quality TMFs per GCP and SOPs.
• Create and execute the study TMF Plan and Index; communicate changes.
• Ensure TMF documents are filed and reviewed on time.
• Support audits, inspections, and issue resolutions.
• Monitor TMF health, risks, and metrics.

Skills

MS Office Suite

eTMF systems

FDA/ICH-GCP

Interpersonal skills

Time management

Education

Bachelor’s degree

Tools

eTMF vendors

Job description

Precision Medicine Group is expanding across LATAM and seeks an experienced Trial Master File Lead II to establish a regional TMF function. You will support project teams in maintaining compliant TMFs per GCP, SOPs, and company standards, across multiple studies.

The role emphasizes leading TMF planning, document indexing, and timely archival, with involvement in audits and risk mitigation. Fluency in English and a Bachelor’s degree are required.