Clinical Documentation Specialist

7 days ago


Brisbane, Queensland, Australia beBeeClinical Full time $90,000 - $120,000
Job Title: Clinical Documentation Expert

About the Role:
This is a pivotal position in our organization, overseeing and managing the Trial Master File (TMF) for assigned clinical trials. As a key member of the Clinical Team, you will play a crucial role in ensuring compliance with ICH-GCP standards and internal processes.

Key Responsibilities:
* 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.

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.

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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