Senior Director, Sponsor Oversight and Monitoring Effectiveness
Core
Founding leader of Sponsor Oversight and Monitoring Effectiveness (SOME) establishing strategy, operating models, and risk-based monitoring approaches to safeguard investigator site quality and confirm vendor activities.
Role type
Senior Director, Clinical Operations (Sponsor Oversight & Monitoring Effectiveness)
Builds
Sponsor oversight operating model, governance, standards, and analytics for CRO monitoring and key vendors
Domain
Biotechnology / Clinical Operations / Drug Development
Required skills
Risk-Based Quality Management (RBQM), Centralized Monitoring, ICH GCP compliance, CRO management, Regulatory inspection support, Portfolio analytics, Team leadership, Vendor performance management
Preferred skills
Advanced degree (Master's, PharmD, PhD) or RN licensure, Neuromuscular disease experience, Hybrid outsourcing model experience, FDA BIMO inspection experience
Technologies
RBQM platforms, Clinical analytics, CTMS, EDC, eTMF
Responsibilities
Design and establish sponsor oversight operating model and governance; Create Study-Specific Oversight Plans (SSOPs); Analyze site and study risk to drive interventions; Safeguard quality at investigator sites via risk-based surveillance; Define and monitor CRO and key vendor expectations; Serve as SME for sponsor oversight during audits and regulatory inspections
Seniority
Senior Director, hands-on IC with people management