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Worldwide Clinical Trials is seeking a seasoned Business Systems Analyst to support the implementation and configuration of clinical systems. You will work with business stakeholders to gather and document requirements, provide technical input through project phases, and ensure alignment with SOPs and regulatory standards.
You will apply both business and technical expertise to select and implement external systems, mentor team members, and produce high-quality documentation for study-specific
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*SUMMARY: Applies both business knowledge and technical expertise to support the implementation of clinical systems for business stakeholders to meet cross-organizational business needs as well as the configuration of systems to meet study requirements by providing analysis, **recommendation, documentation, and delivery of technical solutions.**RESPONSIBILITIES:*_Tasks may include but are not limited to:_Provide technical input to multi-disciplined project teams tasked by senior executives to address particular business needs during all project phases from discovery to retirementProvide analysis input, technical documentation, and other support needed to build a business case for strategic initiatives supporting departments across the corporationApply both business as well as technical expertise to assist in the selection and implementation of external systems and servicesProvide technical support to drive adoption of new solutionsProduce and maintain business requirement, configuration requirement, and technical specification documentation for clinical systems as well as for study-specific software implementations or configurations, such as IRT or cross-system integrationsElicit 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 solutionsManage the requirements change process to ensure traceability and in alignment with departmental processes and toolsEnsure effective communication of business and functional requirements to the project team and stakeholdersProvide expertise and mentorship to the project team and stakeholders in the use of new systemsConfigure 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 practicesProvide quality control review of configurations implemented by others to verify alignment with SOPs and requirementsSupport or execute the design, implementation, and quality control review of reports using business intelligence toolsPerform other duties as assignedThe duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.*OTHER SKILLS AND ABILITIES: *Ability to communicate concisely and effectively in both written and spoken EnglishProficient in the use of common office softwareHighly effective in the use of interviews to uncover fundamental business requirementsStrong presentation skillsAble to work with all levels of stakeholders including senior executivesAbility to quickly become proficient in new systems, including the ability to represent system capabilities via demonstrationSelf-motivated individual who can positively contribute to a team environmentHigh attention to detailHighly creative, and able to adapt to new technologies, concepts and processes, and to make improvements and solve problemsAbility to mentor others in new technologies and best practices*REQUIREMENTS:*Educated to degree level in a relevant discipline or able to demonstrate equivalent work experienceExperience of analysing user or business requirements and documenting themExperience with various modelling techniques such as process modeling, data modeling, system modeling5+ 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 systemsUnderstanding of application and integration infrastructures and how they can and should be utilized to achieve business goalsFamiliarity with user experience concepts and best practicesFamiliarity with risk assessment and mitigation planning strategiesFamiliarity with GxP regulatory requirementsUnderstanding of IRT design and just-in-time drug supply desiredFamiliarity with clinical trials, patient safety, data integrity and associated regulations desiredPromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
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