Analyst Manager
Resume:
Mohith Mittal
******.*****@*****.***
Summary
Life Sciences and IT professional, offering 12+ years of successful experience in software implementation projects, systems integration, requirements life-cycle management, business analysis, test/quality assurance, technology road mapping, and management, strategy, and technology consulting. Proven expertise in Life Sciences industry working within IT, Clinical, Regulatory, R&D and QA. Experienced working with solution delivery teams to ensure projects meet business objectives while remaining aligned to business strategies. Confident individual with exceptional interpersonal skills and team- player/leadership aptitude.
Core Expertise
Functional Areas: • Project Management • Requirements Gathering • Requirements Management • System Validation • SDLC Documentation management • Information Analytics & Dashboards • Clinical Operations • Strategic Roadmap Development • Business Process Analysis, Development, and Improvement • Use Case Modeling • System Integration Technology Deployment • Team Leadership • Consulting Systems/Tools: Electronic Trial Master File (NextDocs, ePharma & Veeva Vault) • CTMS • QMS (Veeva and Trackwise)
• Regulatory Labelling • Regulatory Information Management • ELN • 21 CFR Part11 • GxP • GAMP5 • ECM • Service Now/BMC Remedy • SQL • MS Office
Professional Experience
Project Manager/Sr. Business Analyst (Consultant), Maestro Technologies Inc., Oct 2019 – Current Client – Novartis Inc., East Hanover, NJ
Working as a Business Analyst for Regulatory Labeling system replacement project and was responsible for gathering requirements, documenting them following the CSV process. Project Manager (Consultant), Maestro Technologies Inc., Mar 2018 – Sep 2019 Client – Mallinckrodt Pharmaceuticals Inc., Bedminster, NJ
Managed and led the implementation, migration and/or upgrade of multiple Clinical Veeva Vault systems (eTMF, CTMS, data migration), R&D (Chemical Inventory Management, ELN), Data Integration projects defining the requirements, project scope and deliverables to support the business goals.
Led RFP process; selection of vendors through the contract negotiation phase for multiple projects.
Managed project timelines and worked with implementation vendors, business partners and quality to coordinate implementation activities.
Leading/Participating in system validation activities including managing Change Controls for GxP Systems.
Perform System Admin activities including access management, configuration and maintenance of the system.
Collaborating with the business and other key stakeholders to facilitate the development/update, review, approval and implementation of SOPs, Work Instructions, Job Aids and other Business Process flow documents. Business Analyst/Consultant, Maestro Technologies Inc., Jan 2018 – Mar 2018 Client – Merck & Co., Whitehouse Station, NJ
Worked as a liaison among diverse stakeholders to gather and document business, functional and non- functional requirements via individual interviews and group sessions for QMS implementation and enhancements. Business Analyst/Consultant, Maestro Technologies Inc., Aug 2017 – Dec 2017 Client – Shearman & Sterling, NYC.
Worked as a liaison among diverse stakeholders to gather and document business, functional and non- functional requirements via individual interviews and group sessions for multiple SharePoint projects.
Perform analysis of business processes, business and system requirements for the configuration and implementation of a new software application that supports the internal client business requirements.
Employ structured modeling techniques and tools to describe business functions, processes, workflows, information and technology design.
Develop Use cases and Test Scenarios; Document As-Is and To-Be process flows for existing and future systems to enhance efficiencies and improve support and performance.
Develop and execute Test cases.
Coordinate and facilitate meetings such as business process reviews, project status meetings, and maintain various project status report.
Consultant, Maestro Technologies Inc., Nov 2014 – Jul 2017 Client – Regeneron Pharmaceuticals Inc., Tarrytown, NY
Worked as a liaison among diverse stakeholders to gather and document business, functional and non- functional requirements for GxP Systems including eTMF (NextDocs, ePharma & Veeva Vault), QMS, and CTMS etc.
Lead cross-functional teams through planning, design, configuration and deployment of new clinical systems and enhancements to existing applications. Includes coordinating and participating in system requirements, development, and user acceptance testing and system enhancements.
Collaborate with IT, Quality Systems, QA, Clinical Operations stakeholders on all system integrations, enhancements, and upgrades.
Support the Clinical Operations team in managing vendor relationship on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate.
Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems.
Leading/Participating in system validation activities including managing Change Controls for GxP Systems including writing Test Scripts, IQ/PQ/OQ Scripts.
Support administration activities of Clinical Systems including Veeva Vault eTMF (e.g., User Management, configuration changes etc.,), SharePoint, and Investigator Database & CTMS.
Working with IT and/or vendors in analyzing and resolving technical issues, L2/L3 incidents and perform root cause analysis.
Sr. SharePoint Business Systems Analyst (Consultant), Minneapolis, MN Mar 2014 – Oct 2014 Client – Hennepin County
Worked as a liaison among diverse stakeholders to gather and document business, functional and non- functional requirements via individual interviews and group sessions.
Assisted stakeholders and project leaders with negotiating and prioritizing requirements.
Planning, owning and directing all business analysis activities throughout all phases of a typical SDLC project, including identifying appropriate stakeholders, outlining requirements gathering techniques and deliverables, providing work estimates, prioritizing tasks, ensuring requirements approval and sign-off, and assessing the impact of changes to requirements.
Conducted business and/or functional gap analyses through a detailed understanding of the current and future business processes, and application systems.
Participated in vendor identification and selection, including assessing and comparing various vendor solutions.
Utilized diagrams as appropriate to communicate requirements such as process flows, context diagrams, system interface diagrams, data transformation and field mapping, etc.
Created simple user interface designs to communicate changes to existing systems.
Assisted in project definition and scoping activities.
Supporting the project delivery team during design, construction and testing of the project.
Facilitating UAT by providing guidance on creating test cases and coordinating tasks. Sr. Business Analyst, Tech Mahindra Inc.,
Client – Nestle USA Inc., Glendale CA Dec 2013 – Feb 2014 Client – Applied Materials Inc., Austin TX & Bangalore, India Feb 2010 – Nov 2013
Worked as a Sr. Business Analyst to develop solutions to integrate IT and business process changes to support strategic business needs for various SharePoint and Enterprise Content Management (ECM) projects. Business Analyst, Avantel Softech Ltd, Hyderabad, India Jan 2007 – Jan 2010
Worked as a business analyst for multiple SharePoint projects. Education
Bachelor of Technology in Electrical and Electronics Engineering, JNTU.
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