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Business Analyst

AETEA Health

Business Analyst

National
Full Time
Paid
  • Responsibilities

     Aetea has been asked by their valued client, a leading Biotechnology Company to assist with their need for a Sr. BA for Clinical Information Management Systems. The client and the team you will be working in are great and offer positive challenges in a dynamic environment.To give you an idea of what you will be doing and team you will be doing it with, here is the high-level overview:We are seeking a Senior Business Analyst for Clinical Information Management Systems Responsibilities include but are not limited to:Serves as functional resource and subject matter specialist for Clinical Information Management SystemsActs independently to determine methods and procedures on new or special assignmentsProvides advice, guidance, and training to colleaguesMakes recommendations on vendor selection and oversees vendor activitiesParticipates in projects with varying levels of complexityCollects, documents, and manages user, functional, and technical requirements for regulatory information management systems for the biotechnology business spaceManages application configuration changes following IT Change Management (ITCM) and GxP Change Control proceduresManages qualification/data migration protocols for supported applicationsParticipates in system release and post-deployment support activities with Quality, System Owners, IT Operations, and IT Service DeskProvides application support for validated applicationsInteracts with end users on a regular basis to understand their needs and provide guidance and training on technical solutionsTroubleshoots technical issues and manage problems through to resolutionDevelops processes to ensure high availability of supported application systemsDocuments common resolutions/solutions and application support processes in the IT Service Management knowledgebaseTravel to other sites may be requiredMinimum Requirements:Bachelor or equivalent qualification level, preferably in Biological Science or equivalent combination of education and experience is requiredIT-related certification or equivalent experience, project management experience preferredAt least 8 years of experience working with regulatory information systemsPractical knowledge and application of cGMPs (industry experience/awareness) especially relating to quality assurance processes and proceduresMust possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skillsPractical knowledge of SDLC principles, industry best practices, and assigned system(s) (SDLC/ADLC)Content management, Trial Master File (TMF), SQL, Medidata, Computer System Validation (CSV), and GAMP5 experience a plusExperience with any of the following Clinical solutions highly desirable: Veeva, SASExperience with ITIL, COBIT, or other IT good practices desirableContributes to building high-performing teamsMotivates self and others