💼 Full-Time Position

【Alexion Japan】Clinical development Associate, R&D

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Alexion Pharmaceuticals
📍 Japan, Tokyo, Japan
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Location
Japan, Japan
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Posted
June 11, 2026
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Type
Full-Time
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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.

Job Description

Position Summary

 The Clinical Development Associate (CDA) contributes to Study Delivery with appropriate quality by having primary responsibility for essential document management and coordinate tasks that improve team performance from a wider perspective during the study process.

Principal Responsibilities

  • Trial Master File (TMF) Management

    • Initiate and lead the set up of TMF including tracking of documents.

  • Implement of appropriate quality check of the study-related documents in TMF and check GCP and SOP compliance.
  • Check the status of document storage (Completeness, Timeliness) and share the information to study team.
  • Coordination of Clinical Trial Notification (CTN)
  • Set a schedule of necessary actions for CTN submission
  • Coordinate information collection for CTN and draft it and manage timing of CTN update for regulatory compliance.
  • JNDA/Inspection
  • Prepare index/documents required sub...