Senior Clinical Programmer – Medidata and EDC Lead (Hybrid)

Edwards Lifesciences Gruppe; Redhill (MD); Hybrid; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Clinical Programmer to provide technical expertise in clinical programming, data validation, and trial reporting. You will lead cross-functional teams and coordinate system upgrades while ensuring regulatory compliance across trials.

Ideal candidates have a Bachelor's in a related field with 6+ years in clinical research or data management and strong Medidata programming, SQL, and Excel skills. A hybrid work setup is available in California.

Qualifications

• Bachelor's degree in clinical research, data management, software programming or related field plus 6+ years of experience.
• Extensive experience with EDC (Electronic Data Capture) systems; Medidata programming experience.

Responsibilities

• Provide technical expertise in clinical programming and lead data validation checks and trial reporting in collaboration with stakeholders.
• Lead cross-functional teams in the design and delivery of complex functional modules and provide clinical programming guidance for protocols and CRFs.
• Lead the development of specifications for systems and processes, coordinate system upgrades/enhancements and engage IT for higher level support.
• Develop and present high-level technical training to end-users and mentor junior Clinical Programmers in their training programs.
• Identify resource needs for database implementation and evaluate external resources/vendors.
• Manage daily service providers’ activities for outsourced systems and services used in clinical trials.
• Participate in creating and revising SOPs, work instructions, workflows, forms, and templates to ensure regulatory compliance.

Skills

Medidata programming

Project management

Communication skills

Education

Bachelor's degree in a related field

Master's degree

PhD

Tools

Medidata

SQL

Excel

C#

Job description

Edwards Lifesciences is seeking a Senior Clinical Programmer to provide technical expertise in clinical programming, data validation, and trial reporting. You will lead cross-functional teams and coordinate system upgrades while ensuring regulatory compliance across trials.

Ideal candidates have a Bachelor's in a related field with 6+ years in clinical research or data management and strong Medidata programming, SQL, and Excel skills. A hybrid work setup is available in California.