Clinical Documentation Specialist

8 hours ago

Brisbane, Queensland, Australia beBeeDocumentationspecialist Full time $109,100 - $146,500

We are seeking an experienced Clinical Documentation Specialist to join our team. This individual will oversee and manage clinical documentation, ensuring compliance with regulatory standards.

About the Role

This key member of our Clinical Team will be responsible for setting up, overseeing, and locking clinical documents for assigned studies. They will ensure high-quality documents are ready for inspection at any time, adhering to ICH-GCP guidelines and internal processes.

Key Responsibilities
  • Set up, oversee, and lock clinical documents for assigned studies.
  • Ensure quality documents are ready for inspection at any time, adhering to ICH-GCP standards and internal processes.
  • Lead document kick-off meetings with clinical teams and external partners.
  • Develop, maintain, and update document plans throughout the study lifecycle.
  • Monitor document quality and completeness, providing metrics, reports, and remediation plans when needed.
  • Provide support, guidance, and oversight to junior team members.
  • Act as the main point of contact for document contributors, providing expertise on document processes and systems.
  • Coordinate document readiness for audits and inspections, including timely provision and compliance checks.
  • Lead document reviews, corrective action planning, and secure final archiving of documents.
  • Train and mentor newcomers on document processes and tools.
  • Contribute to digital initiatives and process improvements within document management.
About You

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

You will have a Bachelor's degree in life sciences or a related field, experience in document management or transversal project management, deep knowledge of ICH-GCP, regulatory requirements, and clinical development processes.

You will also have strong project management and organizational skills, excellent written and verbal communication skills, and proficiency with document management systems and Microsoft Office Suite.

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