Senior Clinical Programming Lead: Medidata & EDC Expert

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

Job summary

Edwards Lifesciences is seeking an experienced Clinical Programmer to join the Clinical Affairs team in California. You will provide technical expertise in clinical programming, lead database and tool development, and collaborate with investigators and regulatory bodies to optimize trial data management.

Ideal candidates have 6+ years in clinical research or data management, strong Medidata experience, and proficiency in C# and SQL.

Qualifications

• Bachelor's Degree in a related field; minimum 6 years in clinical research, data management, software programming or related.
• Extensive experience with EDC (Medidata) programming.
• Strong knowledge of Medidata custom functions in C# or SQL.

Responsibilities

• Provide technical expertise in clinical programming and lead development of clinical databases and tools for data validation and trial reporting.
• Lead cross functional teams in design and delivery of complex modules and specifications for systems/processes.
• Develop and present high level technical training for end-users and junior programmers.
• Identify resource needs for database implementation and participate in evaluation of external resources/vendors.
• Manage daily activities of outsourced systems and services used in clinical trials.
• Contribute to creation/revision of SOPs, workflows, forms and templates to ensure regulatory compliance.

Skills

Medidata programming

C#

SQL

EDC systems

Data validation

Microsoft Office

Education

Bachelor's Degree in a related field

Master's Degree or PhD (preferred)

Tools

Medidata

Relational databases

Job description

Edwards Lifesciences is seeking an experienced Clinical Programmer to join the Clinical Affairs team in California. You will provide technical expertise in clinical programming, lead database and tool development, and collaborate with investigators and regulatory bodies to optimize trial data management.

Ideal candidates have 6+ years in clinical research or data management, strong Medidata experience, and proficiency in C# and SQL.