TMF Lead II — Records & Compliance Expert

Premier Research Group; Argentina; On-site; ARS 92,241,000 - 138,361,000; Full time

Job summary

Premier Research is seeking a TMF Lead II to join the Pharmacovigilance and Records Management team. You will drive TMF set-up, maintenance and closure, develop TMF Plans, and ensure compliance with ICH-GCP and global regulations across studies.

This role emphasizes oversight, training, KPI analysis and timely reporting to sponsors and project teams. You will lead TMF transitions, work with the eTMF Administrator, and coordinate quality reviews and inspections.

Qualifications

• 8+ years eTMF systems experience.
• 8+ years TMF management experience.
• 8+ years TMF Reference Model experience.
• 2+ years TMF Lead experience.
• Knowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and global regulations.

Responsibilities

• Acts as primary TMF contact for project teams, Sponsors, auditors and other third parties for assigned studies.
• Works with records specialists and eTMF Administrator on TMF issues and transitions.
• Provides regular TMF status updates to Project Leadership and Functions.
• Develops, signs and maintains TMF Plans and indexes for assigned studies.
• Coordinates TMF audits and inspections as TMF representative for assigned studies.

Skills

eTMF experience

TMF management

TMF Reference Model

TMF Lead experience

Education

Undergraduate degree in records/ information management or related field

Job description

Premier Research is seeking a TMF Lead II to join the Pharmacovigilance and Records Management team. You will drive TMF set-up, maintenance and closure, develop TMF Plans, and ensure compliance with ICH-GCP and global regulations across studies.

This role emphasizes oversight, training, KPI analysis and timely reporting to sponsors and project teams. You will lead TMF transitions, work with the eTMF Administrator, and coordinate quality reviews and inspections.