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.
* 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
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
About Edwards Lifesciences
Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring.