- Extensive experience in data analysis, systems analysis, requirements analysis, documentation, testing, design and development involving various projects in a variety of industries including pharmacovigilance, real world research, insurance, finance, engineering, commercial operations, clinical supply chain
- Creative thinker and analytical problem solver with demonstrated ability to perform in various roles as business analyst, systems and data analyst, developer/designer, tester, project manager, support/maintenance
- In - depth knowledge of SDLC, software design, database design and broad software development experience utilizing Agile and waterfall methodologies
- Excellent understanding of how business needs and objectives translate to defining technical solutions and implementation, and aligning these business needs to IT capabilities
- Ability to manage and mentor people and provide guidance on technical and non-technical issues, and having a unique blend of business and technical skill sets that provides flexibility to take on multiple roles to support an organization's objectives
- Experience with various types of databases, data warehouses and data sources and a have strong understanding of software engineering, programming languages, tools, networking, relational & dimensional modeling, business intelligence, analytics and big data concepts
- Gathered and elicited of project requirements related to clinical supply chain, including cold chain management.
- Analyzed data models of global application that will handle ordering, inventory and distribution of products for clinical sites.
- Analyzed gaps and provided recommendations on database structure, fields and relationships.
- Evaluated information collected from multiple sources, reconcile conflicts, and resolve ambiguities in the requirements.
- Documented business requirements, project charters, process flows, use cases and technical specifications.
- Assisted technical teams in their design and development tasks, including SQL analysis and formulation.
- Served as the conduit between the business users and the development team to align business needs with technical capabilities.
- Communicated and collaborated with business users to understand business needs and functional requirements.
- Analyzed and provided recommendations on testing strategy and implementation.
- Designed and developed test scenarios based on use cases. Created test scripts for validation based on traceability mapping of requirements to test cases.
- Worked with the following tools and applications - SQL Server database, SQL, XML
Project Manager, Business AnalystResponsibilities:
- Successfully managed projects and achieved milestones while ensuring projects complied with scope specifications.
- Provided training and support to end-users, business teams and developers.
- Communicated constantly with management to report project progress, identify issues and risks, and allocate resources. Delivered technical and status briefings of projects to management.
- Liaised among business, database and business intelligence teams.
- Set clear expectations and goals for project teams. Tracked the progress against timeline, milestones and deliverables and revised project plan as needed. Discussed progress, issues, challenges, risks and resource allocation to ensure projects are delivered on or ahead of time.
- Articulated project goals and scope, translated business needs into technical terms, prepared detailed tasks and instilled shared accountability for achieving project milestones.
- Supervised the web development team, ETL team and Business Intelligence teams to provide guidance on project direction and expectations.
- Assisted technical teams in their design and development tasks, including SQL development.
- Authored requirements documentation, test plans and test scripts associated with the projects.
- Tracked testing and validation efforts of projects to ensure that implemented features and functionality are mapped, and adhered to project scope and requirements.
- Worked with the following tools and applications - Oracle database and data warehouse, MicroStrategy reports, SQL, TrackWise, Documentum
Confidential, Pennington NJ
Business Analyst, Data AnalystResponsibilities:
- Managed web portal project planning, design, implementation, testing including client support and training. Guided the work of technical teams.
- Led testing and validation efforts for data loading and database implementation of data sources.
- Ensured effective quality control processes are in place to monitor the deliverables produced.
- Streamlined processes and procedures in for various activities, including ETL, requirements gathering, testing, communication and documentation.
- Formulated user stories, use cases and scenarios utilizing Agile methodology and also defined requirements utilizing waterfall SDLC methodology.
- Established operational procedures to load, manage and consume observational data assets for global research efforts within the organization.
- Managed the gathering, writing and implementing requirements for integrating into Teradata MPP appliance various data assets consisting of claims, EMR/EHR, lab data and registry databases for the Outcomes Research community.
- Contributor to publication, “An Examination of OMOP Common Data Model Vocabulary for Completeness with respect to Drugs, Conditions and Procedures” (Presented at OMOP Symposium 2013).
- Translated business scenarios to test scripts, performed system tests and user acceptance tests and documented test results for data ETL code and web portal.
- Tracked and maintained repository of user story requirements, use cases and scenarios utilizing agile methodology and also defined requirements utilizing waterfall SDLC methodology.
- Analyzed, documented and improved process flows. Authored business procedures and user guides. Authored and reviewed documents related to SDLC cycle.
- Prepared presentations to assist in understanding processes, solutions and alternatives.
- Collaborated with business users, system and database administrators, technical leads, workstream leads and programmers to set expectations and align objectives with business and technical capabilities
- Consolidated mapping and traceability of requirements from adverse events application and associated external interfaces with Argus based user stories and user scenarios
- Provided oversight and analysis of data migration mapping and testing including potential issues, data restrictions, transformation rules and Personally Identifiable Information (PII) considerations.
- Monitored processes on the collection, correction and submission of product information to EVMPD.
- Worked with the following tools and applications - Oracle database, SQL, PL/SQL, Teradata MPP, HPQC, TrackWise, Documentum
Confidential, Springfield NJ
Project Manager, Technical Lead, Business Analyst, DeveloperResponsibilities:
- Managed team of developers in support of Oracle report migration and integration activities resulting in the project being completed ahead of schedule and still adhering to the resource and compliance restrictions set for the project.
- Managed day-to-day operations and provided time critical assistance to international and domestic adverse events (CARES) database users to resolve issues in a timely manner.
- Managed developers and database administrators in keeping the Product Registration reporting project to be completed ahead of schedule.
- Supervised offshore team that support and resolve business and technical issues within service level agreements. Trained support personnel on procedures.
- Managed, planned, directed, technically reviewed and approved the data output and data retrieval processes in support of CAPA commitment. Collaborated with developers, users, compliance analysts and management.
- Coordinated closely with the business units, migration team, product repository team, application team, validation team, system administrators and external groups.
- Developed strategies to reduce development time for report development during integration. Initiated an approach involving changes in the testing procedures but still within constraints of compliance requirements resulting in finishing the project ahead of schedule.
- Provided technical direction and guidance to analysts and developers on documentation, process flow, data analysis and data presentation and interpretation. Performed technical reviews of SQL and PL/SQL to ensure that the implemented technical deliverables meet project requirements and objectives.
- Authored and reviewed validation documents associated with internal audits and for FDA and EMEA audits and submissions
- Performed research, investigations and analysis of data related to incidents, issues and metrics. Provided solutions and strategies on improving issue resolution resulting in reduced incident reporting by 50%.
- Reviewed and analyzed adverse events application architecture and impact with regards to change requests. Configured the application environment as per business requests. Collaborated with the business unit, infrastructure, server teams, administrators and support teams to implement the needed modifications.
- Actively mentored, trained and supervised analysts and developers. Trained new developers with AERS data model, architecture and development processes.
- Set new standards for documentation contents and format. Authored and revised various forms of documentation that includes coding standards & guidelines, installation procedures, training materials, technical manuals, test scripts, technical specifications, process diagrams, and entity relationship diagrams.
- Worked with the following tools and applications - Oracle databases, SQL, PL/SQL, VBA, Windows Scripting