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Professional Summary:Experienced Business Systems/ Validation Analyst along with Project Management and Product Analyst expertise with over 7 years of experience. Known for being a strong leader and good communicator, able to effectively convey complex information to team members and stakeholders. Highly skilled in analyzing data and identifying patterns, ensuring the accuracy and integrity of validation processes. Adept at problem-solving and finding innovative solutions to challenges. Able to drive multiple successful validation projects and contribute to the overall success of the organization. Strong analytical, problem-solving, and communication skills. Committed to delivering robust validation solutions that drive operational excellence and regulatory confidence.EXPERIENCEAmeriSoft Pro Systems LLC, CASr. Business Product Analyst Jul 2023 PresentDepartment: ITLeveraging data analysis, product development, and problem-solving skills, I played a lead role in the implementation, maintenance, and enhancement of IT and business systems. Primary Point of contact in every phase of the project: Analysis and Implementations, Maintenance and Enhancements, Support and Documentation, Data Management, and Integrations plus, Teamwork and Communication. Working closely with Product Owner and other Business Analysts within the program to ensure integrity of the end-to-end solution. Assist Product Owner with Backlog grooming, User Story development and prioritization. Led and created Functional requirements (FSD) and Business requirements (BRD). Modeling the system using Use case diagrams, class diagrams, and state diagrams Led and Organized user acceptance test (UAT) results between users and development team and provided recommendations for Application change requests (ACR). Develop Dashboard reporting solutions from existing Tables and Cubes in Tableau/Power BI reporting tool. Extracted, transformed, and loaded data utilizing ETL Process. Responsible for analyzing data and producing, verifying, and interpreting client reports. Assisted with SDLC lifecycle, including gathering of requirements, application design, testing and implementation. Performed functionality, integration, Regression, usability, and system testing. Developed As-Is flow diagrams and To-Be process flow diagrams then, assessed the changes from current state to identify and deliver the training needs of business users. Walk through process changes with business stakeholders and gain agreement on the process changes.
Adding required information into user stories such as business value, scope of change, non-functional requirements, and acceptance criteria. Created Acceptance Criteria for the User Stories. Participated in Code Reviews, System Testing and UAT followed by production verification, postproduction testing and support. Consolidated multiple Tableau workbooks into single workbook in Tableau report central. Facilitate JAD and walkthrough sessions with SME, User, Management and IT to resolve any issues/ concerns. Conducted Gap Analysis to identify potential opportunities of improvement and recommended them to the Business Partners. Manage workload and priorities to deliver to agree upon project milestones. Working closely with Product Owner and other Business Analysts within the program to ensure integrity of the end-to-end solution. Assist Product Owner with Backlog grooming, User Story development and prioritization. Working closely with Developers, User Representatives and participation in the product design process including specifications and other document reviews.
Involved in all the phases of the Software Development Life Cycle (SDLC) methodologies such as Waterfall, Agile-SCRUM. Involved in various kinds of Unit testing, Acceptance testing and Regression testing of the developed objects and checking the data quality and the functionality of the objects as per the requirements. Self-directed with the ability to break down complex process, assign actions, and manage progress towards a set timeline.Aimmune, A Nestle Health Science Company, CABusiness Systems Analyst/ Computer System Validation Analyst Nov 2020 Jul 2023
Department: IT ValidationPromoted within the same organization to take on additional responsibilities. Successfully lead two teams, overseeing the training and onboarding of new members to existing applications. Conducted comprehensive analysis to determine the specific needs for onboarding and training users on the newly implemented systems as required. Development: Hands-on experience working on Veeva Vault customization/configurations for the CTMS, eTMF, RIM, QualityDocs, QMS, ServiceNow, LMS applications to suit business requirements. Environment Management: Managing the Vault environments, providing user set-up and administration, building, delivering and maintaining required testing environments, managing multiple integration points, etc. Release Management: Managing deployment by coordinating with various internal and external teams; create detailed deployment schedules based on input from project teams, business teams, and stakeholders. Project Management: Estimate and manage the development of new functionality and enhancements to existing ones. Coordinate with various development teams to develop roadmap for the new features. Business and System Analysis: Assisting in gathering and collating business requirements, developing system requirements - including functional and technical specifications, and documenting business processes in workflow diagrams. Support: Providing functional support service and support to the business. Primary point of contact for all users within the organization pre- and post-implementation and lead weekly support calls with users to review and resolve reported issues. Hands-on experience with Service-Now Ticketing tools. Professional Development: Keep abreast of new system features and functionality, proactively recommend system and process improvements.Regulatory Information Management System (RIMs)Administered Veeva Vault RIM system and played pivotal role in optimizing regulatory information management processes and ensuring compliance within the organization.
Proficiently configured and maintained the RIM system to align with regulatory requirements and internal business processes. Collaborated with cross-functional teams to define and implement user roles, workflows, and document types within Veeva Vault. Successfully managed data migration projects, ensuring accurate and secure transfer of regulatory data into Veeva Vault. Identified opportunities for process improvement and automation within the regulatory information management workflow, resulting in enhanced efficiency and reduced compliance risks. Collaborate closely with regulatory affairs, quality assurance, and IT teams to ensure the Veeva Vault RIM system effectively meets the organization's regulatory and compliance needs. Authored all system related documentation: Configuration Specification, Requirement Specification, Work Instructions, User Acceptance Test Plan, supervised the formal testing, reviewed and documented the test results, coordinated with Business and Data management to ensure the configurations meet business requirements.Quality Management System and Quality DocsAdministered Veeva Vault document management and quality management systems ensuring the integrity and compliance of quality documents and supporting the broader quality management initiatives. Configure and maintain the Veeva Vault Quality Docs system to align with quality standards, regulatory requirements, and internal document management processes. Implement and manage QMS processes, procedures, and policies to drive quality and compliance throughout the organization. Coordinate the review and approval of quality documents, including standard operating procedures (SOPs), work instructions, and quality manuals. Facilitate the retrieval of quality documents and data as needed for audits, inspections, and internal quality assessments. Generate reports and metrics to track document status, QMS performance, and compliance. Provide ongoing support, address user inquiries, and troubleshoot issues to maintain a seamless document management experience. Lead the UAT efforts including the validation documentation for both systems.ServiceNowParticipated in configuration, design and deployment of the ServiceNow application streamlining service management, operational efficiency, and enhancing the end-user experience. Configure and manage change management processes in ServiceNow, including change requests, approvals, and reporting. Hold RFCs through ServiceNow for application updates, push feature updates into UAT and then Production, after testing. Collaborate with stakeholders to define and manage catalog items, workflows, and approval processes. Provide training and knowledge transfer to end-users and IT staff as needed. Assisted in developing test cases and scenarios to validate the functional aspects of the ServiceNow application.LMS Coordinate and facilitate UAT sessions with end-users to validate that the LMS meets their training and reporting needs. Document and address user feedback and issues during UAT. Manage course enrollments, user registrations, and completion tracking within the LMS. Generate and analyze LMS usage reports and learner progress reports.Miscellaneous Conducted JAD (Joint Application Development) sessions with teams for better understanding of requirements in coordination with multiple teams. Involved and authored all Change control and Configuration management activities. Conducted Gap Analysis and authored respective validation documentation utilizing risk-based approach; and supported UAT activities. Analyzed and documented business requirements and functional requirements for integration with downstream and upstream systems Experienced in managing/working with offshore teams.Aimmune Therapeutics CAComputer System Validation Analyst Jun 2017 Nov 2020Department: IT ValidationClinical Trail Management System (CTMS)Administration of BioClinica OnPoint platform, SharePoint environment, Monitoring Visit Report(s) configuration, Application administration of clinical study configuration and study design setup.
Monitoring Visit Report(s) Configuration Validated, and managed the Monitoring Module within the CTMS system pre- and post-implementation. Participate in core system development team decisions, bringing user issues to the development team at the vendor and assisting with planned system enhancements to ensure meeting user needs. Primary point of contact for all users within the organization post implementation and lead weekly support calls with users to review and resolve reported issues. Participate in identification of risks and development of mitigation strategies. Authored all system related documentation: Configuration Specification, Requirement Specification, Work Instructions, User Acceptance Test Plan, supervised the formal testing, reviewed and documented the test results, coordinated with Business and Data management to ensure the configurations meet business requirements.Integrating CTMS with EDC/IxRSAssisted in the integration effort between the CTMS system with EDC and IxRS to bring in subject information for managing clinical data within different studies at the organization. Participate in Cross-functional project team discussions to provide support for validation activities. Assisted in drafting and finalizing mapping documents for the integration between different systems. Configured the CTMS environment to make it integration ready to be able to pull in required clinical study information. Coordinated validation activities with IT, Business, Data Management, Vendors and Quality Assurance. Authored all integration related documentation: Validation Plan, Configuration Specification, User Acceptance Test Plan, Requirements Specification, supervised the user acceptance testing, reviewed and documented the test results. Train the team within on data entry and testing within the EDC and IxRS applications in relation to the CTMS system.Electronic Trial Master File System (eTMF)Administration of PhlexGlobal electronic trial master file application including study configuration and study design setup, document management and reporting module. Validated, and administered the eTMF study and document management application pre- and post-implementation. Participate in core system development team decisions, bringing user issues to the development team at the vendor and assisting with planned system enhancements to ensure meeting user needs. Primary point of contact for all users within the organization post implementation and lead weekly support calls with users to review and resolve reported issues. Participate in identification of risks and development of mitigation strategies. Authored all system related documentation: Configuration Specification, Requirement Specification, Work Instructions, User Acceptance Test Plan, supervised the formal testing, reviewed and documented the test results, coordinated with Business and Data management to ensure the configurations meet business requirements.Decommissioning, Retirement and Data Migration
Primary lead in preparing and presenting analysis based on daily data and user activity for retirement and decommissioning of the BioClinica CTMS application. Increased the company s efficiency by 70%. Responsible for preparing the documentation in collaboration with the business owners to align the requirements and configuration of the new CTMS. Participated in several vendor interviews and testing the systems to check if they meet the requirements and finalized the replacement. Authored all system related documentation for decommissioning and retiring the legacy CTMS application. Assisted in data migration activity from relevant current applications to the new CTMS system. Authored all system related documentation for data migration activities.Miscellaneous Participation in auditing vendor validation documentation; user training records, processes, Gap Analysis, Compliance/ Risk assessments. Conducted several workshop sessions and user interviews, to better understand the business domain, requirements and project scope. Handled various planned Change Control and Emergency Change Control for departments by analyzing the category and creating associated change plans and change control documentation. Lead in periodic reviews and part 11 assessments. Ability to work under tight deadlines and effectively handle multiple ongoing projects.EducationMaster of Science, Information Assurance, Wilmington University, USA.Bachelor of Technology, Computer Science Engineering, K L University, India.
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