Lifecycle Safety Systems SME - Literature Search and Review

  • Company: IQVIA
  • Location: United States
  • Posted: December 14, 2017
  • Reference ID: 1722436
Job Description
At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world's largest provider of product development and integrated healthcare services.
As one of FORTUNE's 'Most Admired Companies' in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.


The Safety Systems SME position performs a lead role in supporting theLiterature Search and Reviewbusiness unit and project teams in the analysis, documentation, and management of business requirements throughout the life of the project. The LCS Systems SME will mentor and coach other Business Analysts as they ensure that requirements are fully understood by the technical team before solutions are designed and implemented. This position will adhere to established System Life-Cycle (SLC) and Computer System Validation (CSV) procedures, where applicable, in facilitating innovative solutions that meet the specified requirements and add value to the business. You will collaborate with the Project Manager to document the project scope, objectives, and added value or benefit expectations, using an integrated set of analysis and modeling techniques.

  • Provide deep functional and technical subject matter expertise for theLiterature Reviewbusiness and QI customers.
  • Facilitate and drive escalation and resolution for all systems issues encountered by the business.
  • Primary technical and functional liaison with hosted system vendors as well as QI internal IT partners.
  • Develop and implement processes related to configuration, user acceptance as well as usage for technology and systems.
  • Facilitate and drive configuration/build and user acceptance activities.
  • Identify and remedy systems related people, process and technology gaps.
  • Provide a critical interface to compliance functions through partnership and collaboration with the SCO
  • Perform requirements gathering and analysis in order to provide high quality and detailed requirements, ensuring the closest involvement with, and agreement from, the user community
  • Create prototypes and simulations to provide an accurate, graphical user interface representation, thereby facilitating successful solution design and development
  • Resolve conflicting end-user requirements
  • Follow Quintiles System Life-Cycle (SLC) and Computer System Validation (CSV) procedures, as appropriate
  • Collaborate with the Lead User, or delegated member of the applicable business group, to create a User Requirements Specification (URS) document
  • Collaborate with the Development group to create a Functional Specification (FS) document
  • Model processes to clarify business requirements, and to enhance or re-engineer business processes, prior to, or in parallel with, solution design and implementation, as necessary
  • Produce and review data/information models and preliminary system architecture, as needed
  • As needed, review the Performance Qualification (PQ) document(s) prior to authorization and execution, to ensure
  • that it incorporates previously-captured requirements, and includes tests or test steps that explicitly address each identified user requirement
  • Collaborate with Global IT Solutions functional groups by adhering to established processes to ensure that business requirements are delivered through successful project implementation of optimal, cost-effective solutions
  • Collaborate with developers to ensure adherence to business requirements and UI design specifications
  • Collaborate with project team to ensure timely delivery and quality of all project deliverables
  • Manage BA resources in accordance with project schedules
  • Exhibit confidence and an extensive knowledge of emerging industry practices when solving business problems.
  • Develop training and support programs for global technology and process implementations, as needed
  • Identify initial Business Case requirements & other pre-project activities (e.g., high-level requirements, project scope,
  • objectives)
  • Manage the specified business/systems requirements, working closely with the designated Project Manager to facilitate progress of the project

Job Requirements

• preference for technology and functional experience in PV, Lit search and review; strong technical and business writing skills
• experience with mining and analyzing data from instructured sources; strong knowledge of technical and grammatical editing
• strong knowledge of best practices for user interface design
• ability to conceptualize and think creatively
• ability to understand the business and technical domains
• understanding of modeling languages
• understanding of graphical design and prototyping tools
• expert knowledge of the CSV and SLC processes adopted by Quintiles, and the ability to assist employees in their use
• ability to learn process improvement and re-engineering skills
• ability to understand the project life-cycle
• ability to understand the business and technical domains
• ability to communicate technical concepts to non-technical audiences, and business concepts to technical audiences
• ability to develop training and support programs for global technology and process implementations
• an understanding of current requirements elicitation, analysis, specification, and verification, and the ability to apply
them in practice
• knowledge of process engineering and process improvements
• ability to guide the user in identifying business requirements

• Candidates should possess a Bachelor's degree, and have a minimum of 5-7 years of business analysis experience,
working towards or holding applicable industry accreditation or certification; or equivalent combination of education,
training and experience

EEO Minorities/Females/Protected Veterans/Disabled

* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE's World's Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World's Most Ethical Company® by the Ethisphere Institute

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