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Assoc Safety Scientist Mgr - Technology SME - Literature Team - (1724263) in United States at IQVIA™

Date Posted: 2/4/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description


Purpose:

The Lifecycle (LCS) SARA Literature Subject Matter Expert (SME) is a technology-based position that will perform a managing lead role in supporting the SARA Literature Center business unit with multiple technology automation initiatives, system builds, ongoing validation activities to maintain audit readiness & CFR Part 11 compliance, and support cross functional project teams in the analysis, documentation, and management of business requirements and metrics throughout the life of the project(s). The LCS SARA Literature SME will mentor and coach other Business Analysts to ensure that requirements are fully understood by the technical team before solutions are designed and implemented. Collaboration with Project Managers to document the project scope, objectives, test cases, user acceptance testing, added value or benefit expectations, using an integrated set of analysis and modeling techniques. 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, efficiencies, and audit readiness to the business.


 
RESPONSIBILITIES
    • Provide deep functional and technical subject matter expertise for the LCS SARA Literature Center business and QI customers involving multiple technology automation initiatives, system builds, ongoing validation activities to maintain audit readiness & CFR Part 11 compliance, and support cross functional project teams in the analysis, documentation, and management of business requirements and metrics throughout the life of the project(s).
    • 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 Users, 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.
    • Proactively identify issues and proposed solutions.
    • Suggest, drive, and implement continuous process improvements across the SARA Literature center services to be best in-class delivery with innovative business solutions.
 

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
    • Strong technical and business writing skills.
    • Strong knowledge of technical and grammatical editing.
    • Strong knowledge of best practices for user interface design.
    • Knowledge of Pharmacovigilance requirements.
    • Possess Good Documentation Practices and Communication skills.
    • 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 QuintilesIMS, 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 collaborate, develop & document 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, process improvements, and problem solving skills.
    • Ability to guide the user in identifying business requirements.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Candidates should possess a Bachelor's degree, and have a minimum of 5-7 years of business analysis and project management experience, working towards or holding applicable industry accreditation or certification; or equivalent combination of education, training and experience.
 
 
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.


Whatever your career goals, we are here to ensure you get there!


We invite you to join IQVIA™.


Job ID: 1724263