Business Analyst - US - Remote/Homebased
Worldwide Clinical Trials
- Raleigh, NC
- Permanent
- Full-time
- Provide technical input to multi-disciplined project teams tasked by senior executives to address particular business needs during all project phases from discovery to retirement
- Provide analysis input, technical documentation, and other support needed to build a business case for strategic initiatives supporting departments across the corporation.
- Apply both business as well as technical expertise to assist in the selection and implementation of external systems and services
- Provide technical support to drive the adoption of new solutions
- Produce and maintain business requirements, configuration requirements, and technical specification documentation for clinical systems as well as for study-specific software implementations or configurations, such as IRT or cross-system integrations
- Elicit stakeholders' underlying business needs and transform them into documented business requirements, via multiple and various techniques including interviewing stakeholders and users, applying business knowledge and insight, researching industry best practices and emerging technology, and considering options beyond stakeholders' suggested solutions
- Manage the requirements change process to ensure traceability and alignment with departmental processes and tools
- Ensure effective communication of business and functional requirements to the project team and stakeholders
- Provide expertise and mentorship to the project team and stakeholders in the use of new systems
- Configure systems and integrations between systems to meet the needs of documented requirements at a system or study level, in alignment with relevant SOPs and work practices
- Provide quality control review of configurations implemented by others to verify alignment with SOPs and requirements
- Support or execute the design, implementation, and quality control review of reports using business intelligence tools
- Perform other duties as assigned
- Ability to communicate concisely and effectively in both written and spoken English
- Proficient in the use of common office software
- Highly effective in the use of interviews to uncover fundamental business requirements
- Strong presentation skills
- Able to work with all levels of stakeholders including senior executives
- Ability to quickly become proficient in new systems, including the ability to represent system capabilities via demonstration
- Self-motivated individual who can positively contribute to a team environment
- High attention to detail
- Highly creative, and able to adapt to new technologies, concepts, and processes, and to make improvements and solve problems
- Ability to mentor others in new technologies and best practices
- Educated to degree level in a relevant discipline or able to demonstrate equivalent work experience
- Experience analyzing user or business requirements and documenting them
- Experience with various modeling techniques such as process modeling, data modeling, system modeling
- 5+ years' experience in the conduct of clinical trials and an understanding of the computer systems utilized in support of clinical trials OR in business systems analysis for medium to large back office systems
- Understanding of application and integration infrastructures and how they can and should be utilized to achieve business goals
- Familiarity with user experience concepts and best practices
- Familiarity with risk assessment and mitigation planning strategies
- Familiarity with GxP regulatory requirements
- Understanding of IRT design and just-in-time drug supply desired
- Familiarity with clinical trials, patient safety, data integrity, and associated regulations desired