Data Standards & Metadata Governance Lead
Core
Lead global Data Element Standards (DES) and Metadata Repository (MDR) governance to support Precision Medicine and Clinical Data Hub (CDH) needs.
Role type
Senior Manager, Biomedical Data Stewardship
Builds
Enterprise data standards strategy, interoperable clinical data ecosystems, and inspection-ready metadata repositories.
Domain
Life Sciences / Clinical Data Management / Regulatory Compliance
Required skills
CDISC Standards (SDTM, ADaM), Controlled Terminology, Data Standards Governance, Data Modeling, Database Design, Quality Control, Version Control
Preferred skills
MDR Implementation, Drug Development Lifecycle, Cross-functional Leadership, Process Improvement, Policy Development
Technologies
SDTM, ADaM, MDR
Responsibilities
Collaborate with global teams to align with enterprise standards strategy; Provide subject matter expertise to improve the clinical data and analytics ecosystem; Support developing clinical trials by making data more accessible, interoperable, usable and scalable; Validate MDR entry success and diagnose deviations from Global or Product Standards; Support the development and maintenance of MDR QC reports; Provide DES expertise to stakeholders across R&D; Identify and champion opportunities to improve efficiency and compliance via improved technological solutions.
Seniority
Senior Manager, hands-on IC with leadership responsibilities
