Remote Senior Clinical Data Manager – Phase I HV Studies

Jazz Pharmaceuticals

Philadelphia (Philadelphia County)

Remote

USD 120,000 - 180,000

Full time

8 days ago

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Job summary

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for early-phase HV studies and larger trials. You will collaborate with Clinical Pharmacology, Biostatistics, and Medical Monitors to ensure high-quality, inspection-ready data across phase 1–4 studies.

The role requires 5+ years in pharma data management, strong regulatory knowledge, and the ability to mentor junior staff while maintaining timelines and vendor relationships.

Qualifications

  • 5+ years of Data Management experience in pharma/biotech, including study lead roles.
  • Experience with Phase I HV studies and cross-functional collaboration.
  • Strong regulatory knowledge (ICH/FDA, CDISC).
  • Good project management skills and ability to prioritize tasks.
  • Attention to detail and ability to work in a multi-disciplinary team.

Responsibilities

  • Lead complex clinical studies with minimal guidance.
  • Manage data management activities for HV studies and CROs.
  • Collaborate with medical monitors, statisticians, and CROs to review safety and biomarker data.
  • Lead design/testing of EDC systems and resolve issues.
  • Develop DM documents and train junior staff.

Skills

Data management
Project management
Regulatory knowledge
Cross-functional collaboration
Attention to detail

Education

BA/BS in science/healthcare

Tools

EDC systems
eCRF design
eCOA
IRT

Job description

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for early-phase HV studies and larger trials. You will collaborate with Clinical Pharmacology, Biostatistics, and Medical Monitors to ensure high-quality, inspection-ready data across phase 1–4 studies.

The role requires 5+ years in pharma data management, strong regulatory knowledge, and the ability to mentor junior staff while maintaining timelines and vendor relationships.

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