Senior Manager, R&D Data Stewardship
Americas, US-PA, King of Prussia, CSL Behring, United States
USD 136K-164K (estimate) Senior-level Full Time
Tasks
- Advise governance review boards
- Author SOPs and work instructions
- Define data lineage traceability
- Define metadata standards and governance policies
- Enforce clinical data standards
- Establish access policies and data handling rules
- Govern clinical master data management
- Govern data quality rules
- Govern data transfer specifications
- Map metadata to governance platforms
- Operationalize clinical data strategy
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | ALCOA plus | Audit Trail | CDASH | CDISC | CENtree | CFR Part 11 | Clinical data | Clinical data standards | Data Governance | Data Lineage | Data Management | Data Quality | Data Quality Rules | Data Standards | Data transfer | Data transfer specifications | ECOA | EPRO | GDPR | ICH E6 | ICH E6 R3 | ICH E8 | ICH E8 R1 | Informatica CDGC | Interoperability | Master Data | Master Data Management | MedDRA | Metadata Management | PII | Part 11 | Quality Rules | SDTM | WHODRUG
Education
Regions
Countries
States
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