Senior Early-Phase Clinical Data Management Lead

BioSpace; London (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals seeks an experienced Senior Clinical Data Manager to lead Data Management across Phase I-4 studies. You will partner with Clinical Pharmacology, Medical Monitoring, Biostatistics, and CROs to ensure timely, inspection-ready data supporting safety reviews and dose escalation decisions.

The role requires strong English communication, regulatory knowledge, and expertise in EDC/eCOA systems, with a focus on first-in-human studies. Travel to off-site meetings may be needed.

Qualifications

• Five+ years in Data Management for pharma/biotech or FDA-regulated settings.
• Experience leading Phase I HV studies is required.
• Knowledge of regulatory guidelines and industry standards (ICH/FDA, CDISC).

Responsibilities

• Lead complex clinical studies or related series with minimal guidance.
• Oversee data management activities and CRO/vendor progress.
• Design and testing of EDC systems per company standards.
• Prepare data listings and data edit checks for study timelines.
• Mentor junior DM staff and assist onboarding.

Skills

Data Management

Phase I HV studies

Regulatory knowledge

Project management

Vendor management

Communication skills

Education

BA/BS in science/healthcare

Tools

EDC systems

eCOA systems

CDISC standards

Job description

Jazz Pharmaceuticals seeks an experienced Senior Clinical Data Manager to lead Data Management across Phase I-4 studies. You will partner with Clinical Pharmacology, Medical Monitoring, Biostatistics, and CROs to ensure timely, inspection-ready data supporting safety reviews and dose escalation decisions.

The role requires strong English communication, regulatory knowledge, and expertise in EDC/eCOA systems, with a focus on first-in-human studies. Travel to off-site meetings may be needed.