Associate Director, Central Monitoring

Job not on LinkedIn

🔥 6 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $164.8k - $247.2k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• 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