Process And Quality Document Manager

ICON plc

Not specified; not specified; competitive salary w...
Not specified (assumed office-based or hybrid due to the nature of the role).
Clinical research experience in cro or pharma
Knowledge of ich good clinical practice guidelines
Experience with good documentation practices
ICON plc is seeking a Process and Quality Document Manager to support the development and management of documentation within Global Development Operations. The ideal candidate will have extensive experience in clinical research and document management, ensuring compliance with regulatory standards and facilitating audits

Job Summary

  • The Process & QD Manager supports global development operations by ensuring adherence to R&D documentation standards and process orientation.
  • ICON plc fosters an inclusive environment driving innovation and excellence while shaping the future of clinical development.
  • The role includes coordinating audits, managing training assignments, and representing the organization in the Development Excellence Council.

Matching Summary

Match Score: 85

ICON plc is seeking a Process and Quality Document Manager to support the development and management of documentation within Global Development Operations. The ideal candidate will have extensive experience in clinical research and document management, ensuring compliance with regulatory standards and facilitating audits.

Salary

Not specified; Not specified; Competitive salary with range of benefits including health insurance and retirement planning

Skills & Requirements

Must-have

  • Clinical research experience in CRO or pharma
  • Knowledge of ICH Good Clinical Practice guidelines
  • Experience with Good Documentation Practices
  • Proficiency in MS Office 365 toolset
  • Fluency in English oral and written

Nice-to-have

  • Document management system experience
  • iGrafx process design experience
  • GCP audit and inspection support experience
  • Cross-functional team leadership skills
  • Global mindset and cultural awareness

Key Requirements

  • Minimum 12 years experience in clinical development
  • At least 5 years direct sponsor-CRO interaction
  • Advanced degree in Life Sciences or equivalent
  • Experience as line manager or leader of cross-functional teams

Work Rights

Not specified

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