Trial Master File Lead - Quality & Audit Readiness

Hammerjack Pty Ltd; Philippines; Remote; PHP 1,100,000 - 1,300,000; Full time

Job summary

Hammerjack Pty Ltd is seeking a Trial Master File Lead to oversee TMF/eTMF management plans, build and maintain the electronic TMF system for each study, and ensure training and access controls are maintained. The role requires strong TMF operations experience and regulatory knowledge.

The successful candidate will advise on TMF quality, coordinate with study teams, and support audit readiness while adhering to privacy and security standards.

Qualifications

• Bachelor's degree or international equivalent; preferably Health/ Life Science.
• 5+ years TMF operations experience with FDA/ICH/GCP guidelines.
• Experience leading and auditing TMF quality review efforts.

Responsibilities

• Review and approve TMF/eTMF management plans.
• Build and maintain electronic TMF system for each study.
• Manage user accounts and access controls; ensure training compliance.
• Provide feedback on TMF quality, trends, and compliance with SOPs.
• Support TMF audit readiness and privacy/security standards.

Skills

TMF operations

GCP/ICH knowledge

Audit readiness

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Tools

MS Office

SharePoint

Adobe Acrobat

eTMF system

Job description

Hammerjack Pty Ltd is seeking a Trial Master File Lead to oversee TMF/eTMF management plans, build and maintain the electronic TMF system for each study, and ensure training and access controls are maintained. The role requires strong TMF operations experience and regulatory knowledge.

The successful candidate will advise on TMF quality, coordinate with study teams, and support audit readiness while adhering to privacy and security standards.