About this role

Develop and be responsible for study-specific risk-based monitoring strategies to ensure compliance and efficiency
managing vendor relationships, including onboarding, performance evaluations and resource alignment
Collaborate with Clinical Trial Management teams to design monitoring strategies aligned with RBQM methodologies
Provide input to monitoring plans, ensuring alignment with critical data specifications and SDR/SDV approaches
Oversee and evaluate performance metrics and risk indicators, providing intervention as needed
Act as an SME for monitoring/site management topics
Support inspection readiness activities and participate in regulatory GCP inspections and audits

Applicants must have a Bachelor’s Degree
at least 8 years of proven experience in clinical trial operations, monitoring, and site management
A proven understanding of ICH/GCP standards
familiarity with medical terminology are crucial
experience in risk-based monitoring methodologies
expertise in collaborating with CROs and FSPs

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees at all levels

Senior Manager – Global Site Management and Monitoring

Key skills