Principal Central Monitor / Risk Manager
Core
Strategic leader driving data integrity and patient safety across clinical development programs via advanced centralized monitoring and risk-based quality management (RBQM).
Role type
Principal Central Monitor / Risk Manager (Strategic IC)
Builds
Enterprise-wide RBQM strategies, centralized statistical monitoring frameworks, and risk mitigation plans for clinical studies.
Domain
Clinical Research / Biopharmaceuticals
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
RBQM strategy design, risk assessment and mitigation, centralized statistical monitoring, KRI definition, data quality oversight, cross-functional collaboration, mentorship, report writing, operational metrics analysis
Preferred skills
CRO experience, statistical analysis proficiency, integrated risk planning expertise
Technologies
Electronic study data systems, clinical systems, dashboards
Responsibilities
Design and implement RBQM plans and centralized monitoring frameworks; conduct study risk assessments and define KRIs; lead RBQM governance meetings and data review activities; mentor junior colleagues; engage sponsors on risk management and data cleaning; prepare strategic reports on monitoring insights.
Seniority
Principal, strategy & mentorship
