Associate Director, Central Monitoring

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Brief Description

The Associate Director, Central Monitoring leads Jazz's central monitoring capability within Global Clinical Development Operations, reporting into the Senior Director, Trial Risk Management & Monitoring. This role is accountable for defining, generating, and interpreting centralized data outputs – including Jazz portfolio level key risk indicators (KRIs) and statistical/data-driven signals – and for translating those insights into concrete, risk-proportionate changes in monitoring strategy at the site, study, and CRA level. The Associate Director partners closely with Trial Risk Management, Site Monitoring, Data Management, and study teams to ensure that centralized monitoring is a driving force behind how, where, and how often monitoring resources are deployed across Jazz's sponsored trial portfolio.

Essential Functions/Responsibilities

• Lead and manage the Central Monitoring function, including oversight of central monitoring staff, to deliver centralized, data-driven oversight across Jazz's sponsored clinical trials.
• Define, build, and maintain key risk indicators (KRIs) and centralized statistical monitoring analytics/dashboards at the study, site, and CRA level, in partnership with Biostatistics, Data Management and Business & Technology teams.
• Continuously analyze centralized data trends and risk signals including but not limited to emerging site, study, and CRA-level performance issues, and determine when those signals warrant a change in monitoring strategy (e.g., increased or decreased visit frequency, targeted source data verification, for-cause visits, or CRA reassignment/coaching).
• Own the process for triggering and documenting risk-based changes to monitoring plans, working directly with Trial Risk Management and Site Monitoring leadership to operationalize those changes in the field.
• Support the development of Risk Based Monitoring Strategy Documents and study monitoring plans in alignment with the central monitoring strategy, overall RBQM strategy and ICH E6(R2/R3) guidance.
• Serve as the functional lead for central monitoring technology platforms (e.g., centralized analytics, statistical monitoring, and RBQM systems), partnering with IT, Business & Technology, and/or vendors on configuration, evaluation, and enhancement.
• Present central monitoring outputs, risk trends, and recommended actions to study teams, cross-functional governance forums, and senior leadership on a routine basis.
• Ensure central monitoring documentation, KRI rationale, and escalation history are inspection-ready; serve as subject matter expert during internal audits and regulatory inspections.
• Partner with Site Monitoring leadership to ensure central monitoring findings are effectively communicated to and actioned by field-based CRAs and Lead CRAs.
• Provide leadership, coaching, and development for central monitoring team members, building technical capability in statistical monitoring methodology and analytics tools.
• Champion continuous improvement of central monitoring methodology, including exploration of automation, machine learning, and AI-enabled approaches to risk detection.
• Represent the Central Monitoring function in cross-functional process and technology improvement initiatives, and in governance discussions with external partners and CROs.
• Support RBQM strategy, standards, and training in partnership with the Senior Director, Trial Risk Management & Monitoring.