Associate Director, Global Site Management

KPS Life is hiring an Associate Director, Global Site Management to be fully dedicated to our sponsor client and located on site 3 days per week in either Armonk, NY, Warren, NJ or Cambridge, MA.

We’re looking for a strategic leader with 10+ years of clinical trial experience, proven success managing teams of CRAs and supervisors, and deep expertise in risk-based quality monitoring (RBQM) and FSP/CRO oversight. If you excel at building high-performing monitoring teams, driving inspection readiness, and shaping innovative monitoring strategies across complex portfolios, this senior role offers the opportunity to influence at both the study and program level while collaborating closely with cross-functional leadership.

The Associate Director, Global Site Management is responsible for departmental and/or project-related results, costs, methods, staffing, and managerial planning and integration in support of the sponsor’s clinical trial portfolio of studies. The role directs the development, execution, and oversight of study and program-level risk-based monitoring strategies, and oversees Functional Service Provider (FSP) vendor(s) and CRO Monitoring and Site Management deliverables across a portfolio of studies or a major program.

The incumbent applies expert-level understanding of the site management/monitoring discipline and advanced interpersonal and communication skills to manage a team of supervisors, professionals, and/or a large group of operational support staff, evaluating CRA/CTL resource needs across countries, overseeing onboarding and training, and managing performance and quality through evaluation of performance metrics and risk indicators. This includes direct communication and intervention with study teams, investigator site staff, FSP staff, and CRO staff, and significant influence on department and staff-level outcomes.

The role collaborates with Clinical Trial Management study teams to design fit-for-purpose monitoring strategies, including study risk assessment activities aligned with RBQM methodology, and provides input to financial plans, budgets, and strategy-related matters for the function.

In addition, the role oversees the development of study-specific critical data TSDV specifications, critical data SDR approaches, and monitoring plan reviews, and acts as a senior RBQM subject matter expert to internal and external stakeholder groups. The incumbent plays a lead role in process improvement and innovation initiatives, incorporating innovation into daily execution and management practices, and represents Global Site Management in industry collaborations.

The Associate Director, Global Site Management collaborates closely with Clinical Trial Management, Central Monitoring, GD Quality, Vendor Relationship Management, GCP Quality, Strategic Sourcing and Procurement, and Business Operations.

• Directs the study and program-level monitoring strategy, including identification of critical data and processes, data review methods (including Key Risk Indicators and detection approaches), and the study-specific monitoring visit strategy, across a portfolio of studies.
• Manages budget(s) for teams, large projects, or multiple small/closely related projects, providing monitoring functional expertise to support study budget planning, approval, change orders, and ongoing budget assessments.
• Oversees translation of derived monitoring strategy into Clinical Monitoring Plans and ensures alignment with CRO partners and/or sponsor clinical study teams.
• Oversees development of tSDV specifications in collaboration with CROs, Clinical Study Teams, and Data Management.
• Manages and oversees a specialized team of supervisors, professionals, and/or a large…