Senior Director, Clinical Data Management. - Hybrid
Core
Set strategy and oversee standards delivery framework, governance, and operations for clinical data collection and management.
Role type
Senior Director, Clinical Data Management
Builds
Enterprise metrics, standards libraries, and governance processes for clinical trial data
Domain
Clinical Research / Pharma / Regulatory Compliance
Required skills
Clinical data standards governance, CDISC standards (SDTM, ADaM, CDASH), ICH/GCP guidelines, therapeutic area expertise, stakeholder management, budget management, team leadership
Preferred skills
ACRP-CP certification, PMP certification, clinical database development, data extraction/transformation, FAIR/ALCOA principles
Technologies
EDC, eCRF, SDTM, ADaM, CDISC, HL7, Define.xml
Responsibilities
Define and maintain standard data collection definitions aligned with industry standards, lead organizational initiatives for standards and governance, support audits and inspections, manage operating budgets and resources, provide strategic direction for standards training and best practices, act as escalation point for governance decisions, build senior stakeholder networks across global teams
Seniority
Senior Director, Strategy & People Management