Business Analyst, Regulatory Systems Validation

We are looking to strengthen the Product Management and Quality Team with an experienced Senior business systems analyst professional supporting continuous improvement of IQVIA's Quality Management process. This position will report to Associate director of product management.

RESPONSIBILITIES:
The successful candidate will be responsible for facilitating management of Quality Events and identification and evaluation of Quality Risks through application of Investigator Portal Product Portfolio. Translating data into knowledge and making best use of knowledge are essential to achieving IQVIA's mission of accelerating startup process in trial management while ensuring all regulatory compliance guidelines are met through software development lifecycle process.

• Supporting development of guidance, systems, and tools to gather, organize, visualize, trend, and analyze data resulting from Sponsor Audits, Regulatory Inspections, IQVIA Audits (Investigator Site, Vendor, Internal Process) and QEM Program and relevant external data sources.
• Developing and maintaining Quality Metrics to facilitate identification of potential trends and risks across IQVIA Business Entities and providing actionable insights and recommendations to Process Owners and development teams.
• Supporting Process Owners with management of operational risks, including but not limited to risk identification, evaluation, control and/or monitoring strategies.
• Drive continuous improvement related to related IQVIA technologies (Startup, Feasibility, Training, Safety Notifications and Site Engagement) and associated business processes, working to enhance speed and quality of business outputs, while reducing cost.
• Work with functional area stakeholders to assess and prioritize system and business needs related to technology and process optimization.
• Evaluate business technologies and their underlying processes to ensure quality and consistency related to performance, usability, user best practices and issue resolution
• Documents traceability on a data infrastructure that supports efficient and effective collection, monitoring, ownership and measurement
• Documents and manages the traceability of document to ensure data flow is streamlined and centralized to minimize data redundancy, inaccuracy and incompleteness
• Assist with project meetings, communicate with the team, internal/external partners and senior management
• Establish close partnerships with stakeholders to perform hands-on planning, conduct business requirement sessions, interviews with business, workshops with the business to understand business need, document business requirements related to data strategy, data quality, applications, application interfaces, documentation and maintenance of business requirements, including work flow analysis and process engineering
• Assist development teams in grooming and clarifying requirements to develop processes that help optimize business performance, support internal controls and performance KPIs
• Creates, manages source-to-target data maps, data profiles, data lineage, data dictionary, data design, data flow, business rules, metadata, data quality, SDLC documentation. Defines and documents data standardizations to be performed, data enrichment operations, data validations, data security requirements, and data exception handling processes.
• Participate in design review sessions and exercises around enterprise analytics standards and documentation, including reporting, testing methodology, and data validation

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
• Bachelor’s degree required (a more advanced degree preferred) in science or a related field.
• Two (2) years of QA experience or four (4) years of operational experience in a GCP regulated environment (a combination of experience in GxP regulated environment, including GCP will also be considered).
• 5 Years of Business Analysis Experience
• Experience in the Healthcare Industry with Life Science / Contract Research Organization (CRO) experience along with Experience in Quality Risk Management is a plus.
• Specific experience in CRO related solutions including CTMS, Study Startup, Site Identification/Selection, Safety, Training is a strong plus
• Experience working in a regulated Healthcare environment and a solid grasp of CFR Part 11.
• Advanced capabilities and experience in Change Management and Business Transformation initiatives.
• Track record for effectively communicating and presenting to internal and external customers.
• Extensive interpersonal skills, an ability to influence multi-functional teams, and to manage cross functional team context
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
• Documenting retrospective and current system requirements and maintaining release traceability documentation
• Monitoring traceability from user story-level (including test case documentation) up to system requirement-level
• Manages timelines/project plan for delivery of artifacts and documentation due to the Quality team
• Identify areas of traceability, process and documentation gaps for process improvements, particularly in support of product validation
• Owns release validation documentation, including risk assessments and/or classification and justification of vulnerability and performance test findings
• Developing and maintaining Quality Metrics to facilitate identification of potential trends and risks, providing actionable insights and recommendations to Process Owners and training and development teams.
• SDLC in regulated space Clear understanding of 21 CFR Part 11
• Strong understanding of computer system validation
• Monitoring traceability within the context of agile software development
• Understanding/leading the documentation of root cause analysis
• Ability to contribute to the development of SOPs
• Ability to gather and maintain system requirements with traceability from a diverse group of stakeholders and multifunctional teams
• Ideally, experienced with facilitating audits
• Excellent verbal and written communication skills

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