Associate Director, Central Monitoring
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Job Description
Central Monitoring leader guiding KRI analytics and risk-based oversight for Jazz Pharmaceuticals' clinical trials. Leading monitoring strategy, technology, governance, and analyst development.
Responsibilities:
- Lead and manage the Central Monitoring function across Jazz's sponsored clinical trials
- Define, build, and maintain KRIs and centralized statistical monitoring analytics/dashboards at the study, site, and CRA level
- Analyze centralized data trends and risk signals and determine when monitoring strategy changes are warranted
- Own the process for triggering and documenting risk-based changes to monitoring plans
- Support development of Risk Based Monitoring Strategy Documents and study monitoring plans
- Serve as functional lead for central monitoring technology platforms
- 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 communicate findings to field-based CRAs and Lead CRAs
- Provide leadership, coaching, and development for central monitoring team members
- Champion continuous improvement, including automation, machine learning, and AI-enabled risk detection
- Represent Central Monitoring in cross-functional process and technology initiatives and 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
- Significant, hands-on experience in central/statistical monitoring or risk-based quality management (RBQM)
- Demonstrated expertise defining, operationalizing, and interpreting KRIs
- 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
- Experience working with large, multi-source clinical trial datasets
- Strong data analytics and interpretive skills
- People leadership experience, including managing and developing a team of central monitoring analysts/associates
- Excellent written, verbal, and presentation skills
- Strong business acumen
- 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 travel, under 10%
- Bachelor's degree in a life science, nursing, or related discipline required
- Pharmaceutical or biotechnology industry experience required
- Prior people management experience required
Benefits:
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
- Remote work arrangement
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