IT Business Systems Analyst, Clinical Affairs Edwards Lifesciences
Irvine, CA

Job Description

The IT Business Systems Analyst (BSA) has accountability for supporting the Clinical Affairs operations across several business units. Additionally, you will implement and optimize small to mid-sized solutions that improve business process efficiencies and effectiveness. The BSA is a domain expert of clinical technologies, applications, and solutions to improve business processes.

Responsibilities:

* Provide operational support, in the form of, system administration/configuration and subject matter expertise to ensure clinical trial activities are executed in a timely fashion


* Serve as liaison between Clinical business process owners in Business Units, Functional Groups, Regions, and IT


* Keep current with clinical technologies in support of business process and recommend technologies that will increase cost effectiveness


* Document and develop in-depth knowledge of applications and interfaces used to support business processes


* Lead and/or manage small to mid-sized projects / enhancements to reengineer and optimize business processes and systems


* Configure and test systems to execute features, integration, and reporting per Software Development Lifecycle (SDLC)


* Familiarity with validated IT systems, with the ability to write requirement documents, specification documents, and test scripts leading to the execution of validation plans


* Work with stakeholders in developing ROI based business cases for enhancements and small to mid-sized projects


* 10% Travel



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Required Education, Experience, & Skills:

* A Bachelor's degree in computer science, business, technology or related field is required. A Master's degree in computer science, business, technology or related field is preferred.


* A minimum of 3 years' experience in a Business Systems Analyst role is required with a Bachelor's Degree.


* Ability to develop and maintain business and technical documentation


* Ability to assist with mapping, troubleshooting, and optimizing interfaces for multiple systems


* Experience working in complex, matrixed environments


* Prior experience working in complex global business environment


* Experience managing small to mid-sized IT projects


* Knowledge of Good Clinical/Good Documentation Practices (GxP) processes


* Knowledge of FDA guidelines for Software Quality, Systems Validation, and System Development Lifecycle preferred


* Moderate understanding and knowledge of clinical information systems such as Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), etc.


* Experience with identifying, integrating, and managing SaaS solutions and external vendors


* Strong analytical and logical problem-solving skills


* Strong interpersonal, written, and verbal communication skills


* Organizational and project management skills a plus


* Possess and display sound judgment, initiative, flexibility, and detail-orientation


* Competent in handling multiple tasks with attention to detail, and perform duties with minimal supervision


* Ability to adapt to new technologies


* Ability to adapt to rapidly changing environment


* Demonstrates creativity to develop and implement innovative solutions and changes