Associate Director, Monitoring

Associate Director, Central Monitoring

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.

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.

Required Knowledge, Skills, and Abilities:

• Typically, 8-10+ years of clinical research/clinical operations experience in the pharmaceutical or biotechnology industry, including significant, hands-on experience in central/statistical monitoring or risk-based quality management (RBQM).
• Demonstrated expertise defining, operationalizing, and interpreting KRIs, and translating centralized data signals into concrete site-, study-, and CRA-level monitoring decisions.
• Strong working knowledge of ICH E6(R2/R3), risk-based quality management principles, and applicable global regulatory requirements.
• Hands-on experience with central monitoring/statistical analytics platforms, CTMS, and EDC systems; comfort working with large, multi-source clinical trial datasets.
• Strong data analytics and interpretive skills, with the ability to distill complex data trends into clear, actionable recommendations for non-technical stakeholders.
• People leadership experience, including managing and developing a team of central monitoring analysts/associates.
• Excellent written, verbal, and presentation skills, with demonstrated ability to influence and align cross-functional and senior stakeholders.
• Strong business acumen and the ability to balance operational excellence, quality, and resource considerations in monitoring strategy decisions.
• Proven…