Associate Director, Global Site Management

kps life; New Jersey; Hybrid; USD 180,000 - 240,000; Full time

Job summary

KPS Life is seeking an Associate Director, Global Site Management to lead RBQM-driven site monitoring strategies across a sponsor portfolio. The role requires building strong, senior-level relationships with CROs, FSPs, and study teams while guiding global site operations.

Located on site 3 days per week in Armonk, NY, Warren, NJ or Cambridge, MA, you will drive strategy, ensure inspection readiness, and mentor a team of monitoring professionals to deliver high-quality data and compliant trial

Qualifications

• 10+ years of clinical trial experience in RBQM and supplier oversight.
• Proven success managing CRAs and supervisors.
• Strong strategic leadership and cross-functional collaboration.
• Experience with ICH GCP and regulatory standards.
• Able to design and oversee monitoring strategies for studies and programs.

Responsibilities

• Directs the study and program-level monitoring strategy across a portfolio of studies.
• Manages budgets for teams, large projects, or multiple related projects.
• Oversees CRO partners and FSP/CRA performance, escalation, and issue resolution.
• Leads inspection readiness activities and regulatory GCP inspections/audits.
• Establishes productive investigator site relationships and cross-functional communications.

Skills

Team management

RBQM knowledge

RBM knowledge

CRO/FSP oversight

Clinical trial ops

Vendor management

Strategic leadership

Communication

Cross-functional collaboration

Education

Bachelor’s Degree

Job description

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.

Position Summary

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.

Key Responsibilities

• 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 group of operational support staff; typically conducts performance reviews and provides input on direct reports within the aligned Job Family Group.
• Represents Global Site Management in Clinical Study Team Meetings and Quality Review Meetings, providing senior input to study teams on existing and emergent operational risks.
• Directs site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, sponsor SOPs, and local operational and regulatory requirements (SQV, SIV, IMV, and COV).
• Provides senior oversight of CRO partner site management activities, including CRO CRA engagement, resource allocation, and performance, escalating and resolving issues as appropriate.
• Oversees CRO partner and FSP CRAs/CTLs to ensure sites meet performance expectations related to study delivery, including subject identification, enrolment, retention, and timely delivery of quality data.
• Establishes and maintains productive investigator site relationships, including targeted senior-level site engagement alongside study-assigned CRAs (CRO or sponsor FSP).
• Establishes and maintains a productive, senior-level relationship with CRO counterparts as part of functional oversight responsibilities, mitigating and resolving complex site management/monitoring issues.
• Directs performance management and oversight of FSP and CRO partners through proactive monitoring of metrics and KPIs, including oversight of onboarding activities across a portfolio of studies.
• Partners with and influences Directors and/or other senior management to align on ‘operational health’ messaging at cross-functional and governance forums (e.g., Joint Operating Committee, FSP Model Management Team).
• Leads inspection readiness activities and represents Global Site Management in Regulatory GCP inspections and/or audits.
• Acts as a senior subject matter expert (SME) and sponsor point of contact for monitoring/site management topics, applying advanced technical knowledge to solve complex matters.
• Applies advanced knowledge of functional objectives, prior experience, and critical thinking to make independent decisions on diverse, complex matters; escalates only the most significant site management-related issues.
• Maintains regular communication with key cross-functional counterparts and leads applicable forums/meetings to optimize performance and delivery at investigator sites (e.g., CTM, GTO, SSU, VRM).
• Leads process improvement initiatives, identifying opportunities to initiate operational changes and policy modifications as appropriate.

Qualifications & Requirements

Knowledge, Skills, and Abilities Required

• Demonstrated experience managing a team of supervisors and/or professionals, including performance reviews and staff development.
• Extensive experience working in a risk-based quality operating model.
• Advanced knowledge of the drug development process and expert knowledge of clinical trial operations, clinical monitoring, and site management processes, and associated industry regulations.
• Strong familiarity with medical terminology.
• Excellent interpersonal and advanced communication skills; demonstrated collaborative as well as independent working style.
• Ability to build and influence relationships with internal stakeholders and senior management (e.g., Directors).
• Ability to translate a design strategy into an operating framework across a portfolio of studies or a major program.
• Strong critical thinking and independent decision-making ability on diverse, complex matters.
• Proactive and self-motivated; able to determine how to use resources to meet objectives and timelines on generally self-initiated assignments.
• Strong organizational skills, with experience contributing to financial plans, budgets, and resource/strategy planning.
• Working knowledge of ICH/GCP.
• Up to 25% travel required.

Education & Experience

• Bachelor’s Degree (minimum).
• 10+ years of relevant experience, including demonstrated experience managing supervisors and/or professional staff.