Risk Based Study Management Lead
Core
Provide end-to-end risk oversight for assigned clinical studies, ensuring risks to patient safety, data quality, and trial integrity are proactively identified and managed.
Role type
Senior clinical study management lead (risk-based monitoring)
Builds
Clinical studies for pharmaceutical sponsors
Domain
Clinical research / Life sciences
Required skills
Risk-based monitoring principles, ICH-GCP knowledge, regulatory standards, cross-functional facilitation, data trend analysis, root cause analysis, inspection readiness
Preferred skills
Centralized monitoring experience, KRIs/KPIs interpretation, sponsor partnership management
Technologies
None stated
Responsibilities
Lead and maintain study-level risk assessments, chair cross-functional risk review meetings, review centralized monitoring outputs and trends, support issue escalation and mitigation planning, ensure alignment with sponsor expectations, contribute to inspection readiness
Seniority
Senior, hands-on IC