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Pharma Business Systems Analyst (Clinical Operations and R&D)

Company: The Ascent Services Group
Location: San Mateo
Posted on: November 23, 2020

Job Description:

Please contact Meera Makam ator email for any questions Remote for now This is a Business Systems Analyst who sits in IT. It is an IT-aligned individual who understands both the technology and the business and is thus able to elicit requirements, provide documentation, and lead IT projects with a full understanding of the technology implications Preference here is a strong background in IT Business Systems Analysis and preferred understanding of the clinical and regulatory processes.Experience using ServiceNow for Change Management, Incident Management, and Incidence Reporting is a plus. Other IT skills will include eliciting and documenting requirements, reviewing technical specifications and configuration specifications from vendors, reviewing vendor design documentation and ensuring alignment with business and system requirements. Position Summary The Business Systems Analyst II, IT RD position provides technical and business analysis expertise for the Ultragenyx RD functional areas ofClinical Operations, Regulatory Operations, and Clinical Outcomes in Routine Evaluation (CORE).The position will support the evolution of our IT service portfolio and applications, while partnering with the Sr. Manager, IT RD and business stakeholders to ensure alignment between the IT and functional requirements. This position partners closely with key business teams to elicit technical and functional requirements, provide strategic analysis of systems and processes, and participate in vendor evaluations. This position The Business Systems Analyst II will use his or her knowledge of the technologies and business processes to execute technical implementations in project or maintenanceenhancement initiatives.The position will be the boots on the ground for the IT RD team. Responsibilities including, but not limited to Requirements Skills A minimum of 3-5 years of Information Technology experience A minimum of 3 years experience in biotech, pharmaceutical or life sciences RD required Strong knowledge of the biopharmaceutical, clinical operations and regulatory processes Experience working with Clinical Operations, CORE, or Regulatory Operations business teams Experience supporting the implementation of both small- and large-scale IT systems Excellent communication skills, with comfort presenting to and working with functional stakeholders Independent and proactively seeks opportunities to improve the IT department and services, as well as own career journey Highly motivated with the ability to drive results Must have a Bachelors degree in Information Technology, Computer Sciences, Life Sciences, or related discipline Execute IT projects and maintenance initiatives in alignment with the IT Research and Development (RD) strategic plan and roadmap for Clinical Operations, Regulatory Operations, and CORE functional departments Operate within the annual IT RD budget Use industry knowledge to recommend innovative technology solutions to improve organizational maturity in clinical informatics, data management, data visualization and analysis, and statistical programming Lead technology projects, programs or initiatives with confidence and expertise Assist Sr. Manager, IT RD in vendor management as needed, to ensure vendor project teams and professional services teams are operating as expected Elicit system and functional requirements from key stakeholders in IT, Clinical Operations, Regulatory Operation, and CORE Document system and functional requirements as needed to support new and existing system implementations Contribute to Standard Operating Procedure or Work Instruction creation Execute incident and problem management processes for Functional Departments platforms, systems, applications, and services Collect and distribute key performance metrics (KPIs) and reporting needs for IT RD services Manage IT RD systems list and license tracking Contribute to continuous improvement efforts within the IT Department, and advocate for IT RD capabilities and services across Ultragenyx Collaborate with multiple external technology and managedprofessional services vendors Perform all activities in compliance with relevant requirementsstandards and controls (e.g., GxP, SOX, GDPR, CCPA) Please contact Meera Makam ator email for any questions

Keywords: The Ascent Services Group, San Mateo , Pharma Business Systems Analyst (Clinical Operations and R&D), Other , San Mateo, California

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