TMF Master File Lead - Clinical Trials Compliance

SYSGEN RPO; Philippines; On-site; PHP 1,200,000 - 2,000,000; Full time

Job summary

SYSGEN RPO is seeking an experienced TMF Operations professional to lead the review and approval of TMF/eTMF management plans, and to complete the build and ongoing maintenance of electronic TMF systems for each study.

The role emphasizes ensuring TMF completeness, quality, and timeliness, providing guidance on quality documents, audits, and archival procedures while coordinating with study teams and internal stakeholders.

Qualifications

• Bachelor’s degree or international equivalent in a health/science field.
• 5+ years TMF operations experience with FDA/ICH/GCP guidance.
• Experience leading quality review efforts of TMF and team.
• Experience with electronic TMF systems and archiving.
• Fluent English, strong documentation and auditing skills.

Responsibilities

• Review and approve TMF/eTMF management plans.
• Build and maintain the electronic TMF system for studies.
• Manage user accounts, access, and training proof.
• Provide TMF quality information and guidance to teams.
• Support TMF audits and inspection readiness.
• Maintain study status tracking and archive procedures.
• Lead TMF SOP development and continuous improvements.

Skills

Presentation

Independent judgment

Relationship building

MS Office

SharePoint

Acrobat

Document formatting

Tracking systems

Stakeholder coordination

Multitasking

Work under pressure

English proficiency

Quality awareness

Education

Bachelor’s degree or international equivalent

Health/Life Sciences background preferred

Relevant experience equal to degree

Tools

MS Office

SharePoint

Acrobat

Electronic TMF System

Job description

SYSGEN RPO is seeking an experienced TMF Operations professional to lead the review and approval of TMF/eTMF management plans, and to complete the build and ongoing maintenance of electronic TMF systems for each study.

The role emphasizes ensuring TMF completeness, quality, and timeliness, providing guidance on quality documents, audits, and archival procedures while coordinating with study teams and internal stakeholders.