Senior TMF Lead - Records & Compliance Expert

73 Premier Research Argentina; Argentina; On-site; ARS 900,000 - 1,200,000; Full time

Job summary

Premier Research is seeking a TMF Lead II to join our Pharmacovigilance and Records Management team. You will oversee TMF setup, maintenance, and closures across studies, ensuring compliance with ICH-GCP, FDA CFR Part 11, and global regulations.

This role requires strong leadership, training, KPI reporting, and collaboration with sponsors, auditors and project teams to ensure audit readiness and timely document submissions.

Qualifications

• High school diploma or equivalent required.
• Undergraduate degree preferred in records and information management, library science, clinical science or related field.
• 8+ years eTMF systems experience and TMF management experience.
• 8+ years TMF Reference Model experience.
• 2+ years TMF Lead experience.
• Strong knowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and global regulations.

Responsibilities

• Acts as primary TMF point of contact for project teams, Sponsors, auditors and other third parties for assigned studies.
• Works with records specialists and eTMF Administrator on system issues and TMF scope.
• Provides TMF status updates to Project Leadership on document submissions.
• Develops and maintains TMF Plans and indexes; participates in TMF audits and inspections.
• Coordinates quality reviews of TMFs per TMF SOPs and Plans.

Education

High school diploma or international equivalent

Undergraduate degree preferred in records management or related field

TMF Lead experience

TMF Reference Model experience

eTMF systems experience

Knowledge of ICH-GCP and regulatory standards

Job description

Premier Research is seeking a TMF Lead II to join our Pharmacovigilance and Records Management team. You will oversee TMF setup, maintenance, and closures across studies, ensuring compliance with ICH-GCP, FDA CFR Part 11, and global regulations.

This role requires strong leadership, training, KPI reporting, and collaboration with sponsors, auditors and project teams to ensure audit readiness and timely document submissions.