Lead Clinical Data Manager - Early Phase HV Studies (Remote)

Jazz Pharmaceuticals, Inc.; Greater London; Hybrid; GBP 80,000 - 110,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for phase 1-4 studies, including HV studies. You will collaborate with clinical pharmacology, biostatistics, medical monitoring, and CROs to ensure timely, inspection-ready data and robust data capture.

You will design eCRFs, eCOA forms, EDC systems, manage edit checks, data listings, and provide mentoring to junior DM staff, while ensuring adherence to ICH/FDA CDISC guidance and regulatory

Qualifications

• Minimum five years of data management experience in pharma/biotech.
• At least two years leading Phase I HV studies.
• Strong knowledge of regulatory guidelines and CDISC standards.
• Experience with EDC systems and data management processes.
• Excellent communication and vendor collaboration skills.

Responsibilities

• Lead data management activities for early phase HV studies.
• Collaborate with cross-functional teams to review data.
• Design and test EDC and eCOA systems.
• Develop data management documents and data edit checks.
• Manage timelines and monitor CRO/vendor progress.

Skills

Data Management

Project management

Regulatory knowledge

English communication

Vendor management

Education

BA/BS in science

Tools

EDC systems

eCRF design

IRT systems

Job description

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for phase 1-4 studies, including HV studies. You will collaborate with clinical pharmacology, biostatistics, medical monitoring, and CROs to ensure timely, inspection-ready data and robust data capture.

You will design eCRFs, eCOA forms, EDC systems, manage edit checks, data listings, and provide mentoring to junior DM staff, while ensuring adherence to ICH/FDA CDISC guidance and regulatory