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About the Role

The Associate Director, Central Monitoring leads Jazz's central monitoring capability within Global Clinical Development Operations. This role defines, generates, and interprets centralized data outputs to drive risk-proportionate changes in monitoring strategy. The Associate Director partners with various teams to ensure centralized monitoring is a key driver of resource deployment across Jazz's clinical trial portfolio.

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.
Continuously analyze centralized data trends and risk signals, determining when signals warrant a change in monitoring strategy.
Own the process for triggering and documenting risk-based changes to monitoring plans, working with leadership to operationalize those changes.
Support the development of Risk Based Monitoring Strategy Documents and study monitoring plans.
Serve as the functional lead for central monitoring technology platforms, partnering with IT and/or vendors on configuration, evaluation, and enhancement.
Present central monitoring outputs, risk trends, and recommended actions to study teams, governance forums, and senior leadership.
Ensure central monitoring documentation, KRI rationale, and escalation history are inspection-ready.
Partner with Site Monitoring leadership to ensure central monitoring findings are communicated to and actioned by field-based CRAs and Lead CRAs.
Provide leadership, coaching, and development for central monitoring team members.
Champion continuous improvement of central monitoring methodology, including exploration of automation, machine learning, and AI-enabled approaches.
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.

Requirements

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 experience partnering with Site Monitoring/CRA teams, Biostatistics, and Data Management in a matrixed environment.
Enthusiasm for innovation, including application of AI and advanced analytics to clinical trial oversight.
Business travel, including international <10%.

Skills

Central monitoring
Statistical monitoring
Risk-based quality management (RBQM)
Key risk indicators (KRIs)
Data analytics
ICH E6(R2/R3)
CTMS
EDC systems
People leadership
Communication skills
Presentation skills
Business acumen
AI
Machine learning

Location

Remote

Work Type

Full-time

Experience Level

8-10+ years of clinical research/clinical operations experience
People leadership experience

Education Level

Bachelor's degree in a life science, nursing, or related discipline required
Advanced degree (e.g., MS, MPH) preferred

Salary/Compensations

$164,800.00 - $247,200.00

Benefits

Discretionary annual cash bonus or incentive compensation
Discretionary equity grants
Medical insurance
Dental insurance
Vision insurance
401k retirement savings plan
Flexible paid vacation

About the Company

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases.
The company has a diverse portfolio of marketed medicines, including therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Jazz's patient-focused and science-driven approach powers research and development advancements across its pipeline in oncology and neuroscience.
Jazz is headquartered in Dublin, Ireland with global operations.

Equal Opportunity

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.