Global Clinical Data Standards, Senior Therapeutic Area Lead - Hybrid

539

Base: $173,200.00 - $272,600.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
10 years work experience
6 years data management experience
4 years clinical data standards development
The Global Clinical Data Standards, Senior Therapeutic Area Lead position at Merck involves leading and maintaining clinical data standards and overseeing data collection processes in compliance with health authority regulations. The role requires extensive experience in clinical data management and standards development, with responsibilities including training, mentoring, and cross-functional collaboration

Job Summary

  • The Senior GCDS TA Lead serves as a subject matter expert in data standards to support clinical data collection and transformation management compliant with health authority regulations.
  • This role requires leading cross-functional data governance reviews, defining KPIs, and ensuring consistency of therapeutic area work with current standards.
  • The successful candidate will receive a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility.

Matching Summary

Match Score: 85

The Global Clinical Data Standards, Senior Therapeutic Area Lead position at Merck involves leading and maintaining clinical data standards and overseeing data collection processes in compliance with health authority regulations. The role requires extensive experience in clinical data management and standards development, with responsibilities including training, mentoring, and cross-functional collaboration.

Salary

Base: $173,200.00 - $272,600.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 10 years work experience
  • 6 years data management experience
  • 4 years clinical data standards development
  • CDISC CDASH SDTM ADaM expertise
  • HL7 standards knowledge
  • ICH and GCP guidelines knowledge

Nice-to-have

  • Metadata management platforms
  • Programming for data insights
  • Innovative spirit
  • Cross-functional collaboration
  • Continuous improvement projects

Key Requirements

  • B.A. or B.S. degree in life sciences or computer science
  • Minimum 10 years total work experience
  • Advanced knowledge in two or more therapeutic areas
  • Expertise in submission deliverables like SDRG and Define.xml

Work Rights

Not specified

Tailored Resume

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