Associate Director, Central Monitoring

🕒 il y a 29 jours

🌐 États-Unis, Royaume-Uni – Distant

🇺🇸 États-Unis – Télétravail 🇬🇧 Royaume-Uni – Télétravail

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $164 800 - $247 200 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

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Jazz Pharmaceuticals

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2003

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals est une entreprise biopharmaceutique dédiée au développement de médicaments innovants répondant à des besoins médicaux sérieux non satisfaits. Avec un fort engagement envers la recherche et le développement, Jazz se concentre sur la création de thérapies transformatrices, mettant en avant l'importance de la collaboration, de la diversité et de l'engagement des employés dans ses opérations. L'entreprise est fière de transformer la vie des patients grâce à ses offres de produits significatives et une culture qui favorise l'enthousiasme et la flexibilité.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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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