Senior Manager, R&d Data Stewardship

Seqirus

Clinical data standards cdisc sdtm adam
Regulatory compliance ich e6 r3 21 cfr part 11
Master data management mdm governance
This role serves as the definitive stewardship voice for clinical data within a newly created Technology Enabled Sciences group focused on Data Excellence

Job Summary

  • This role serves as the definitive stewardship voice for clinical data within a newly created Technology Enabled Sciences group focused on Data Excellence.
  • The position requires enforcing global regulatory expectations including ALCOA+ principles and ensuring strict blinding integrity for high-risk clinical data.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and a culture of inclusion and belonging.

Matching Summary

This role serves as the definitive stewardship voice for clinical data within a newly created Technology Enabled Sciences group focused on Data Excellence.

Skills & Requirements

Must-have

  • Clinical data standards CDISC SDTM ADaM
  • Regulatory compliance ICH E6 R3 21 CFR Part 11
  • Master Data Management MDM governance
  • Data lineage traceability and metadata workflows
  • Clinical operations workflow knowledge

Nice-to-have

  • Experience with Veeva Suvoda or Sycamore platforms
  • Familiarity with Databricks AWS Redshift architectures
  • Knowledge of unstructured data and Knowledge Graphs
  • Hands-on experience with Informatica CDGC tooling
  • Understanding of semantic relationships in data

Key Requirements

  • 5-8+ years pharmaceutical/biotech industry experience
  • Bachelor's or Master's degree in Life Sciences or related field
  • Deep functional knowledge of CDISC frameworks and ontologies

Work Rights

Not specified

Tailored Resume

Cover Letter