Clinical Trial Master File Specialist

2 weeks ago

Brisbane, Queensland, Australia beBeeClinical Full time $100,000 - $120,000
TMF Manager Position Overview

We are seeking a highly skilled TMF Manager to oversee and manage the Trial Master File (TMF) for assigned clinical trials. The ideal candidate will have strong clinical documentation expertise, exceptional organisational skills, and the ability to collaborate effectively across cross-functional teams.

This role involves setting up, overseeing, and locking clinical TMFs for assigned studies. Ensuring the quality of Clinical Department Trial Master Files is ready for inspection at any time is also crucial. The selected candidate will lead TMF kick-off meetings with clinical teams and CROs.

  • Set up, oversee, and lock clinical TMFs for assigned studies.
  • Ensure the quality Clinical Department Trial Master Files are ready for inspection at any time.
  • Lead TMF kick-off meetings with clinical teams and CROs.
  • Write, maintain, and update TMF Plans throughout the study lifecycle.
  • Monitor TMF quality and completeness, providing metrics, reports, and remediation plans when needed.
  • Provide support, guidance, and oversight to Associate TMF Managers and Clinical Documentation Administrators.
  • Act as the main point of contact for TMF contributors, providing expertise on TMF processes and eTMF / EDMS systems.
  • Coordinate TMF readiness for audits and inspections, including timely document provision and compliance checks.
  • Lead TMF reviews, corrective action planning, and secure final archiving of TMFs.
  • Train and mentor newcomers on TMF processes and tools.

Strong experience in clinical documentation and trial master file management is essential. The selected candidate must be able to balance detail and strategy while driving compliance and efficiency.

Qualifications & Experience
  • Bachelor's degree (life sciences or related field preferred).
  • Experience in TMF management or transversal clinical project management.
  • Deep knowledge of ICH-GCP, TMF regulations, and clinical development processes.
  • Strong project management and organisational skills, with a rigorous eye for detail.
  • Excellent written and verbal communication skills.
  • Proficient with EDMS / eTMF systems and Microsoft Office Suite.
  • Strong collaboration and influencing skills.
  • Entrepreneurial mindset and openness to innovation.
  • Strategic thinking and customer focus.
  • Ability to train, mentor, and inspire others.

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