Senior CDM Analyst: Lead Multi-site Clinical Data Excellence

Edwards Lifesciences Gruppe; Irvine (CA); Vor Ort; USD 108.000 - 153.000; Vollzeit

Zusammenfassung

Edwards Lifesciences in Irvine, CA seeks a data management professional to drive complex data collection and quality across multi-site studies. You will design data capture requirements and support training to ensure data integrity throughout study conduct.

You will develop data management plans, lead CDM activities, and collaborate with clinicians, IT, and regulatory teams to optimize data quality and timely study delivery.

Qualifikationen

• Bachelor’s Degree in related field; 5 years of clinical research experience including data management.
• Experience with EDC (Electronic Data Capture) systems.
• Preferred: experience with AI tools Copilot & Claude.
• Strong problem-solving and communication skills.

Aufgaben

• Create complex metrics to identify trends in data and remediation across studies.
• Define clinically complex data collection requirements (eCRFs, CRFs, edit checks).
• Lead project management for multi-site/multi-cohort studies and timelines.
• Develop and maintain data management deliverables (DMPs, training materials).
• Evaluate data errors; provide guidance to the clinical team.
• Site/User Administration and access guidance; support training.
• Lead development/review of CDM SOPs and related documents.

Kenntnisse

Clinical data management

Clinical data entry

EDC systems experience

Communication skills

Ausbildung

Bachelor’s Degree in related field

Tools

Microsoft Office Suite

EDC systems

Jobbeschreibung

Edwards Lifesciences in Irvine, CA seeks a data management professional to drive complex data collection and quality across multi-site studies. You will design data capture requirements and support training to ensure data integrity throughout study conduct.

You will develop data management plans, lead CDM activities, and collaborate with clinicians, IT, and regulatory teams to optimize data quality and timely study delivery.