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.
\n
Brief Description:
\n
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.
\n
\n
Essential Functions/Responsibilities
\n
\n - 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.
\n
\n
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.
\n
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).
\n
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.
\n
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.
\n
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.
\n
Present central monitoring outputs, risk trends, and recommended actions to study teams, cross-functional governance forums, and senior leadership on a routine basis.
\n
Ensure central monitoring documentation, KRI rationale, and escalation history are inspection-ready; serve as subject matter expert during internal audits and regulatory inspections.
\n
Partner with Site Monitoring leadership to ensure central monitoring findings are effectively communicated to and actioned by field-based CRAs and Lead CRAs.
\n
\n - Provide leadership, coaching, and development for central monitoring team members, building technical capability in statistical monitoring methodology and analytics tools.
\n
\n
Champion continuous improvement of central monitoring methodology, including exploration of automation, machine learning, and AI-enabled approaches to risk detection.
\n
Represent the Central Monitoring function in cross-functional process and technology improvement initiatives, and in governance discussions with external partners and CROs.
\n
Support RBQM strategy, standards, and training in partnership with the Senior Director, Trial Risk Management & Monitoring.
\n
\n
\n
Required Knowledge, Skills, and Abilities
\n
\n - 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).
\n
\n
Demonstrated expertise defining, operationalizing, and interpreting KRIs, and translating centralized data signals into concrete site-, study-, and CRA-level monitoring decisions.
\n
Strong working knowledge of ICH E6(R2/R3), risk-based quality management principles, and applicable global regulatory requirements.
\n
Hands-on experience with central monitoring/statistical analytics platforms, CTMS, and EDC systems; comfort working with large, multi-source clinical trial datasets.
\n
Strong data analytics and interpretive skills, with the ability to distill complex data trends into clear, actionable recommendations for non-technical stakeholders.
\n
People leadership experience, including managing and developing a team of central monitoring analysts/associates.
\n
Excellent written, verbal, and presentation skills, with demonstrated ability to influence and align cross-functional and senior stakeholders.
\n
Strong business acumen and the ability to balance operational excellence, quality, and resource considerations in monitoring strategy decisions.
\n
Proven experience partnering with Site Monitoring/CRA teams, Biostatistics, and Data Management in a matrixed environment.
\n
\n - Enthusiasm for innovation, including application of AI and advanced analytics to clinical trial oversight.
\n
\n
Business travel, including international <10%.
\n
\n
\n
Required/Preferred Education and Licenses
\n
\n - Bachelor's degree in a life science, nursing, or related discipline required; advanced degree (e.g., MS, MPH) preferred.
\n
\n
Pharmaceutical or biotechnology industry experience required; prior people management experience required.
\n
\n
LI-DM1
\n
#LI-Remote
\n
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $164,800.00 - $247,200.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.
