Document Control Specialist

1 day ago

Brisbane, Queensland, Australia beBeeClinical Full time
Clinical Documentation Expert

As a Clinical Documentation Expert, you will play a crucial role in overseeing and managing the Trial Master File (TMF) for assigned clinical trials, ensuring compliance with ICH-GCP standards and internal processes.

This position is ideal for someone with strong clinical documentation expertise, exceptional organisational skills, and the ability to collaborate effectively across cross-functional teams.

About the Role

  • 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.
  • Contribute to digital initiatives and process improvements within TMF management.

About You

You will bring strong experience in clinical documentation and trial master file management, with the ability to balance detail and strategy while driving compliance and efficiency.

Key Responsibilities

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

We Offer

A supportive team environment that fosters growth and development.

An opportunity to work on diverse projects and contribute to the company's mission.

Flexible working arrangements to promote work-life balance.

Ongoing training and professional development opportunities.

About Us

We provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Our Values

We value diversity, equity, and inclusion in our workplace.

We strive to create an environment where everyone feels welcome and valued.

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