TMF Lead II: Trials Records & Compliance Leader

Premier Research Group; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

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

You will provide oversight, training, KPI reporting, and support for audits and inspections. This role requires 8+ years in eTMF systems and TMF management, TMF Reference Model experience, and TMF Lead experience.

Qualifications

• Minimum of a high school diploma or international equivalent required. Undergraduate degree preferred from an accredited institution majoring in records and information management, library science, clinical, science or health related field preferred - or – an equivalent level of clinical trials records management experience.
• 8+ years eTMF systems experience required.
• 8+ years of Trial Master File management experience required.
• 8+ years TMF Reference Model 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.

Education

High school diploma

Undergraduate degree in records/information management or related field

Tools

eTMF systems

TMF Reference Model

Job description

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

You will provide oversight, training, KPI reporting, and support for audits and inspections. This role requires 8+ years in eTMF systems and TMF management, TMF Reference Model experience, and TMF Lead experience.