Senior Manager Global Site Management
Core
Design and lead risk-based monitoring strategies and site management for global clinical trial portfolios to ensure high-quality operational execution and inspection readiness.
Role type
Senior Manager, Global Site Management
Builds
Global clinical trial programs
Domain
Biotechnology / Clinical Research
Required skills
Risk-based monitoring (RBQM), site management, CRO/FSP oversight, ICH-GCP guidelines, regulatory compliance, stakeholder management, performance metrics analysis
Preferred skills
Targeted Source Data Verification (tSDV), global multi-country study experience, Key Risk Indicators (KRIs), inspection readiness, process improvement
Technologies
Clinical trial management systems, RBQM frameworks
Responsibilities
Lead development of study-specific risk-based monitoring strategies; Partner with Clinical Trial Management to identify critical data and risks; Provide oversight of CRO and FSP monitoring activities; Evaluate performance metrics and operational trends; Collaborate on study planning, budget forecasting, and inspection readiness; Establish relationships with investigator sites and external partners.
Seniority
Senior Manager, hands-on leadership