Senior Clinical Data Manager, Phase I HV (Remote)

Jazz Pharmaceuticals; Greater London; Remote; GBP 70,000 - 100,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for early-phase HV studies and multi-disciplinary programs. The role partners with Clinical Pharmacology, Medical Monitoring, Biostatistics, and Phase I units to ensure timely, inspection-ready data for safety reviews and dose escalation decisions.

The candidate will manage data management tasks across studies, oversee CROs, and contribute to study governance, with extensive experience in EDC/eCOA

Qualifications

• At least five years’ experience in Data Management for pharma/biotechnology, or equivalent in FDA-regulated environment.
• Minimum two years leading Phase I (HV) studies.
• Understanding regulatory guidelines and industry standards (ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA).
• Strong project management skills with ability to prioritize multiple tasks.
• Excellent written and verbal English; able to work with a global team.

Responsibilities

• Lead data management activities for early phase HV studies (SAD, MAD, bioavailability, etc.).
• Represent Data Management on the study team and manage CRO/vendors.
• Lead design/testing of EDC systems; resolve related issues with the team.
• Develop data management documents and data edit check specifications.
• Mentor junior Data Management staff and assist with onboarding.

Skills

Data Management

Phase I HV studies

Regulatory guidelines

Project management

Attention to detail

Communication

Education

BA/BS in scientific/healthcare field

Tools

EDC systems

eCOA

IRT

Job description

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for early-phase HV studies and multi-disciplinary programs. The role partners with Clinical Pharmacology, Medical Monitoring, Biostatistics, and Phase I units to ensure timely, inspection-ready data for safety reviews and dose escalation decisions.

The candidate will manage data management tasks across studies, oversee CROs, and contribute to study governance, with extensive experience in EDC/eCOA