Senior Clinical Programming Lead - Medidata & EDC Expert

Edwards Lifesciences; California (MO); On-site; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences in California is seeking an experienced Clinical Programmer to join the Clinical Affairs team. You will provide technical expertise in clinical programming, build databases and tools for data validation, and work with investigators, medical professionals, patient groups, and regulators to optimize patient outcomes.

You will lead cross-functional teams in designing complex modules, develop system specifications, and guide IT for higher level support.

Qualifications

• Bachelor's Degree and a minimum of 6 years experience in clinical research, data management, software programming or related field or equivalent work experience based on Edwards criteria.
• Extensive experience with EDC (Electronic Data Capture) systems; Medidata programming experience.

Responsibilities

• Provide technical expertise in clinical programming functional area and lead in the development of clinical databases, and tools and programs for data validation checks, and clinical trial reporting in collaboration with key stakeholders
• Lead cross functional teams in the design and delivery of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report forms
• Lead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users
• Develop and present high level technical training to end-users, including providing guidance to lower-level Clinical Programmers in their training program development
• Identify resource needs for database implementation and participate in the evaluation of external resources/vendors
• Manage daily service providers’ activities for outsourced systems and services used in clinical trials
• Participate in the creation and revision of new or existing SOPs, work instructions, workflow, forms, and templates to ensure clinical systems and activities are in compliance with the regulatory and company requirements

Skills

Project management

Communication

Cross-functional leadership

Education

Bachelor's Degree

Master's Degree

PhD

Tools

Medidata

SQL

C#

Excel

Job description

Edwards Lifesciences in California is seeking an experienced Clinical Programmer to join the Clinical Affairs team. You will provide technical expertise in clinical programming, build databases and tools for data validation, and work with investigators, medical professionals, patient groups, and regulators to optimize patient outcomes.

You will lead cross-functional teams in designing complex modules, develop system specifications, and guide IT for higher level support.