Manager, Quality Clinical Risk Management
Core
Lead clinical quality-risk management across trials and programs, translating risk signals into proactive mitigation and ensuring inspection readiness.
Role type
Manager, independent clinical quality-risk leadership
Builds
Quality risk monitoring, inspection narratives, and submission readiness for clinical trials
Domain
Pharmaceutical R&D / Clinical Quality
Required skills
Clinical risk assessment, mitigation strategy development, quality issue investigation, CAPA planning, inspection readiness, cross-functional leadership, regulatory compliance interpretation, team coaching
Preferred skills
None stated
Technologies
None stated
Responsibilities
Identify and assess key risks in clinical protocols; lead reviews of risk areas and mitigation progress; drive quality risk monitoring reviews; develop and ensure consistent interpretation of quality issues; lead Cross-Functional Trial Teams for pre-submission reviews; drive ongoing inspection readiness activities; provide independent advice on research quality and compliance; support quality integration of acquired assets
Seniority
Manager, independent decision-making with cross-functional influence
