Remote RWE Study Lead: Global Observational Research

Jazz Pharmaceuticals, Inc.; Cambridge, Greater London; Híbrido; GBP 113.000 - 169.000; Jornada completa

Descripción de la vacante

Jazz Pharmaceuticals, Inc. is seeking a Senior Manager for Real World Evidence responsible for leading end-to-end observational studies, including registries and EHR/claims analyses.

You will oversee study planning, site coordination, data management, and vendor oversight to deliver high-quality RWE outputs for regulatory, medical affairs, and value evidence. The role requires expertise in GPP, privacy regulations, and cross-functional leadership across HEOR, Biostatistics, Data Analytics, and

Formación

• 6+ years of research project management experience in biotechnology, pharmaceuticals, or CROs.
• 3+ years leading observational studies, including prospective registries/cohorts and retrospective data analyses.
• Deep knowledge of real-world data sources (e.g., EHRs, claims, registries) and GPP/ISPOR guidelines.

Responsabilidades

• Lead end-to-end planning, execution, and closeout of global observational studies (prospective and retrospective).
• Oversee study documentation, data transfer, and IRB/ethics submissions for observational projects.
• Manage external vendors/CROs, budgets, timelines, and data quality KPIs.
• Coordinate cross-functional Study Execution Teams and risk mitigation activities.
• Ensure compliance with HIPAA/GDPR and internal SOPs in all activities.

Conocimientos

Study management

Vendor management

Cross-functional leadership

GPP knowledge

RWE data sources

Communication skills

Educación

Bachelor's degree in Life Sciences

Advanced degree preferred

Herramientas

eTMF

CTMS

EDC

Data governance platforms

Descripción del empleo

Jazz Pharmaceuticals, Inc. is seeking a Senior Manager for Real World Evidence responsible for leading end-to-end observational studies, including registries and EHR/claims analyses.

You will oversee study planning, site coordination, data management, and vendor oversight to deliver high-quality RWE outputs for regulatory, medical affairs, and value evidence. The role requires expertise in GPP, privacy regulations, and cross-functional leadership across HEOR, Biostatistics, Data Analytics, and