Senior Clinical Data Manager – Remote (Early-Phase)

Jazz Pharmaceuticals, Inc.; Philadelphia (Philadelphia County); Remote; USD 120,000 - 180,000; Full time

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Senior Clinical Data Manager to lead data management activities for Phase 1-4 studies. You will partner with clinical pharmacology, medical monitoring, biostatistics and CROs to ensure timely, inspection-ready data for safety reviews and dose escalation decisions.

The role requires strong knowledge of regulatory guidelines, experience in HV studies, and ability to mentor junior staff while driving process improvements across the Data Management function.

Qualifications

• Five years’ experience in Data Management in pharma/biotech or FDA-regulated setting.
• Experience leading Phase I HV studies (minimum two years).
• Knowledge of regulatory guidelines (ICH/FDA, CDISC, GCDMP, 21 CFR 11).
• Strong project management, prioritization, and communication skills.

Responsibilities

• Lead complex clinical studies or series of related studies with minimal guidance.
• Lead DM activities for early phase HV pharmacology studies (SAD/MAD, food effect, DDI, bioavailability, bioequivalence, FIH).
• Represent Data Management on the study team.
• Manage data management activities and CRO/vendor progress.
• Collaborate with cross-functional teams to review safety, PK/PD, ECG, labs, and biomarkers data.
• Design and test EDC systems per company standards.
• Lead development of DM documents and data listings.

Skills

Data Management

Phase I HV

Vendor management

eCRF/eCOA design

EDC systems

Project management

Education

BA/BS in science

Tools

EDC systems

Job description

Jazz Pharmaceuticals, Inc. is seeking a Senior Clinical Data Manager to lead data management activities for Phase 1-4 studies. You will partner with clinical pharmacology, medical monitoring, biostatistics and CROs to ensure timely, inspection-ready data for safety reviews and dose escalation decisions.

The role requires strong knowledge of regulatory guidelines, experience in HV studies, and ability to mentor junior staff while driving process improvements across the Data Management function.