Senior Clinical Data Manager AI-Driven CDM

Regulatory Jobs; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards seeks a Clinical Data Management professional to join our Clinical Affairs team in Irvine. You will design and manage data capture, lead multi-site studies, and ensure data quality and regulatory compliance.

The role requires a Bachelor's degree with 5+ years in clinical research and EDC experience; familiarity with AI tools like Copilot and Claude is a plus, along with strong communication and project management skills.

Qualifications

• Bachelor’s degree in a related field with 5+ years of clinical research and data management experience.
• Experience with Electronic Data Capture (EDC) systems.

Responsibilities

• Creating complex metrics to identify trends in data and remediation, utilizing tools to assess training needs and improve data status during study conduct.
• Defining and specifying clinically complex data collection requirements for assigned studies and coordinating user acceptance testing.
• Leading project management activities for multi-site studies to bring clinical studies online, including meetings, timelines, and stakeholder communications.
• Developing and maintaining Data Management deliverables including DMPs, training materials, and user aids in regulatory compliance.
• Evaluating data errors and collection issues; providing guidance to clinical teams for resolution.
• Performing Site/User Administration to manage database access and user rights.

Skills

EDC experience

Data management

Communication skills

Project coordination

Education

Bachelor's degree

Tools

Copilot

Claude AI

Microsoft Office

Job description

Edwards seeks a Clinical Data Management professional to join our Clinical Affairs team in Irvine. You will design and manage data capture, lead multi-site studies, and ensure data quality and regulatory compliance.

The role requires a Bachelor's degree with 5+ years in clinical research and EDC experience; familiarity with AI tools like Copilot and Claude is a plus, along with strong communication and project management skills.