Lead Clinical Programming Specialist - Medidata & EDC

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences in California is seeking a senior Clinical Programmer to advance clinical data management and programming for our trials. You will develop databases, EDC validation, and Medidata programming in collaboration with investigators and regulatory partners.

The role requires strong cross-functional leadership, experience with CRF design, system integration, and training end-users. We offer competitive salary, hybrid work model, and focus on patient outcomes.

Qualifications

• Bachelor's degree required with 6+ years in clinical research, data management, or related field.
• Extensive experience with EDC systems; Medidata programming experience required.
• Advanced degrees (Master's or PhD) or equivalent work experience preferred depending on Edwards criteria.

Responsibilities

• Provide technical expertise in clinical programming and lead in development of clinical databases and reporting tools.
• Lead cross-functional teams in design and delivery of complex modules; guide case report forms and protocols.
• Collaborate with IT for system upgrades and integration; develop training for end-users.
• Oversee resource needs for databases and manage outsourced services in trials.
• Contribute to SOPs, work instructions, and regulatory/compliance documentation.

Skills

Project management

Technical communication

Presentation skills

Cross-functional collaboration

Data management

Education

Bachelor's degree

Master's degree or PhD preferred

Clinical research education or equivalent

Tools

Medidata

C#

SQL

Job description

Edwards Lifesciences in California is seeking a senior Clinical Programmer to advance clinical data management and programming for our trials. You will develop databases, EDC validation, and Medidata programming in collaboration with investigators and regulatory partners.

The role requires strong cross-functional leadership, experience with CRF design, system integration, and training end-users. We offer competitive salary, hybrid work model, and focus on patient outcomes.