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MK
Merck KGaA·1 month ago
1 month ago

Head of Data Standards & CRF Design (all genders)

Maroussi, GreeceFull-timeSenior · 10-15 years

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About this role

We are currently hiring a Head of Data Standards & CRF Design to lead a global team in clinical data standards and CRF design. Oversee metadata governance and ensure regulatory submission readiness. Ideal for experienced leaders in clinical data standards within the pharmaceutical or biotech sector.

Skills

  • change leadership
  • define.xml
  • inspection-ready metadata governance
  • metadata governance
  • crf design
  • cdisc open rules
  • anated crf
  • executive communication
  • ai-enabled metadata and protocol-to-crf automation
  • sdtm
  • vendor management
  • stakeholder influence
  • hl7 fhir-to-cdisc interoperability
  • quality oversight
  • annotated crf
  • cdisc standards
  • edc study build standards
  • risk management
  • regulatory submission readiness
  • cross-functional integration
H1B sponsor likely
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