TMF Lead II: Regulatory Excellence & Impact

Premier Research Group; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Premier Research in Oregon seeks a TMF Lead II to oversee Trial Master File management within our Pharmacovigilance and Records Management group. You will lead TMF setup, maintenance and closure, ensuring compliance with ICH-GCP and global standards.

The role includes developing TMF plans, supervising staff, and providing training and KPI reporting to sponsors and project teams. A strong track record in TMF governance is required.

Qualifications

• 8+ years eTMF systems experience required.
• 8+ years of Trial Master File management experience required.
• 2+ years TMF Lead experience required.
• Knowledge of ICH-GCP, ISO14155, FDA CFR Part 11 and global regulations related to the investigational drug and device industry required.

Responsibilities

• Acts as primary TMF point of contact for project teams, Sponsors, auditors and other third parties for assigned studies.
• Works directly with the records specialists assigned to their studies.
• Works with eTMF Administrator to identify and assist in the resolution of system related issues if/as needed.
• Reads and understands the TMF scope of work to be performed on assigned studies.
• Identifies any out-of-scope activities and reports to department management for change order consideration on assigned studies.
• Provides regular TMF status updates to Project Leadership and Functions on the quality and timeliness of document submissions on assigned studies.
• Assists with monitoring the security, environment and access control of Secure File Room (SFR) facilities (if applicable).
• Monitors compliance to TMF SOPs and TMF Plans for assigned studies.
• Performs live, web-based and/or recorded TMF process and systems training for Premier project teams, Sponsor and other Third Parties on assigned studies.
• Performs all departmental budgeted activities for assigned studies.
• Develops, signs and maintains TMF Plans, TMF Transition Plans and indexes for assigned studies.
• Participates in TMF audits and inspections as TMF representative for assigned studies.
• Coordinates project team quality reviews of TMFs in accordance with TMF SOPs and TMF Plans for assigned studies.

Skills

TMF Lead experience

TMF Reference Model

eTMF systems

Trial Master File management

Regulatory knowledge (ICH-GCP / ISO141

Education

Undergraduate degree in records management or health-related field

High school diploma or international equivalent

Tools

eTMF platform

Job description

Premier Research in Oregon seeks a TMF Lead II to oversee Trial Master File management within our Pharmacovigilance and Records Management group. You will lead TMF setup, maintenance and closure, ensuring compliance with ICH-GCP and global standards.

The role includes developing TMF plans, supervising staff, and providing training and KPI reporting to sponsors and project teams. A strong track record in TMF governance is required.