Clinical Transparency Specialist

1 week ago


Sydney, New South Wales, Australia beBeeCompliance Full time $80,000 - $110,000

Job Summary:

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This role is responsible for coordinating transparency activities, ensuring content compliance with applicable health agency regulations, and providing document management services.

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Key Responsibilities:

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  • Coordinate operational aspects of transparency activities, including collecting and preparing content for anonymization.
  • Partner with a third-party provider to ensure content is properly anonymized.
  • Issue and release anonymized content using appropriate systems.
  • Apply data transparency standards to ensure compliance with regulatory requirements.
  • Provide document management services, including indexing and archiving approved documents.
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Requirements:

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  • Experience with redaction and protection of personal information in the scientific field.
  • Clinical document specialist or scientific writing support experience is preferred.
  • 1-3 years of experience in clinical trial management, regulatory submissions, or publishing is preferred.
  • Basic understanding of clinical trial or submission document disclosure requirements.
  • Knowledge of electronic document management systems and proficiency in Adobe Acrobat.
  • Proficiency in disclosure-related Health Authority and industry regulations and guidelines.
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What We Offer:

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  • A competitive compensation package.
  • A diverse culture that rewards high performance and nurtures talent.
  • Annual leave entitlements, health insurance options, retirement planning, and an Employee Assistance Programme.


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