Senior Clinical Documentation Specialist

7 hours ago


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

We are seeking an experienced Clinical Documentation Specialist to join our team.

Key Responsibilities:
  • Establish and maintain clinical document management systems for assigned studies.
  • Ensure the quality of Clinical Department Trial Master Files is consistently high, ready for inspection at any time.
  • Lead clinical teams and CROs in TMF kick-off meetings.
  • Develop, update, and maintain TMF Plans throughout the study lifecycle.
  • Monitor TMF quality and completeness, providing metrics, reports, and remediation plans when needed.
  • Support Associate Clinical Documentation Specialists and Clinical Documentation Administrators.
  • Act as the main point of contact for clinical contributors, providing expertise on clinical 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 newcomers on clinical 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.
Requirements & Experience:
  • Bachelor's degree (life sciences or related field preferred).
  • Experience in clinical documentation 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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