SUMMARY

• 10 years of end - to-end Business Analysis and Project Management experience in teh IT and Life Sciences industry
• Experience working in dynamic environment in MNCs (Multi-National Companies) wif teams spread all over teh globe
• Expertise in full software life cycle implementation, upgrades, rollout, and go-live assistance till post implementation support
• Expert understanding of SDLC (Software Development Life Cycle) and Agile flavored development methodologies (Waterfall, Scrum, and Agile Framework)
• Extensive experience in engagement wif senior client stakeholders located in US, European, and APAC market
• Proficiency in leading requirement workshops, requirement gathering, requirement analysis, design, & project estimations
• Managed offshore teams of developers and testers for teh project modules
• Responsible for tracking issues/risks/action items and supporting client team to execute UAT
• Experienced facilitator wif considerable workshop preparation, delivery, and write-ups
• Technical and business knowledge of EDC (Electronic Data Capture) tools to provide solutions to pharmaceutical clients in building clinical studies

TECHNICAL SKILLS

• Product Lifecycle Management
• Agile / Scrum Methodologies
• Stakeholder Engagement
• Requirements Gathering
• Clinical Data Management
• Business Process Mapping
• Regulatory Processes - 21 CFR Part 11 & GCP
• Clinical Trial Management
• Pharmaceutical R&D Processes
• Workshop Planning & Facilitation
• Oracle WebCenter Content
• Oracle Life Sciences Data Hub
• Oracle Inform Architect
• Oracle Central Designer
• Rational CLM Suite (RRC, RTC and RQM)
• Axure RP Pro (UI Design)
• DataLabs
• Microsoft Visio
• HP ALM & HP Quality Centre
• Seapine

PROFESSIONAL EXPERIENCE

Confidential, New York

Functional Project Lead

Responsibilities:

• Functional Project Lead for teh MDR module wif a team size of 25 members
• Custom Software Developments: Managed all phases of teh software development lifecycle (SDLC) for custom solutions of MDR.
• Responsible for leading regular workshops & presentations wif client stakeholders for system demonstrations and process clarifications
• Work closely on functional design wif technical architects and other SMEs (Subject Matter Experts)
• Generating detailed business and system requirements supported by use cases, wireframes, and workflows
• Responsible for creating project plan wif teh Programme lead
• Led teh data migration workstream for MDR focusing on teh data quality and adaptability to downstream systems
• Deliver MDR training to business consisted of more than 100 users

Tools: MDR, HP ALM, Rationale CLM Suite

Confidential

Lead Business Analyst

Responsibilities:

• Lead Business Analyst for teh UCR (Unstructured Content Repository) module wif a team size of 10 members
• Responsible for hosting regular workshops & presentations wif client stakeholders for system demonstrations and process clarifications
• Work closely on functional design wif technical architects and other SMEs (Subject Matter Experts)
• Generating detailed business and system requirements supported by use cases, wireframes, and workflows
• Responsible for documenting requirements using IBM Rational tool.
• Responsible to run configuration workshop wif business to record all teh configuration points in teh module
• Create training material and user guides for teh module
• Work wif senior client stakeholders and analyzed all system requirements and came up wif solution involving WebCenter Content configurations and customizations.

Tools: Axure RP, Rational RRC, SharePoint, Oracle LSH, Oracle WebCenter Content, and Microsoft Visio

Confidential

Lead Business Analyst

Responsibilities:

• Lead Business Analyst for teh CSDW module wif a team size of 7 members
• Responsible for delivering teh module using Oracle LSH.
• Requirement Gathering and Analysis
• Process Reengineering and Workflow Design
• Requirement documentation using IBM Rational tool
• Participated in Design Reviews and Functional Validations of UI Screens
• Responsible for creating training material and conducted training for Business Users

Tools: Rational CLM Suite (RRC, RQM and RTC), SharePoint, Oracle LSH, and Microsoft Visio

Confidential

Study Design Consultant

Responsibilities:

• Worked as a Study Design Consultant who works closely wif teh client to guide them in study design and edit check development to deliver a high-quality EDC system.
• Provided ongoing support in client testing of DataLabs proprietary software, trouble-shooting, and resolving technical issues
• Provided overall business and systems analysis and design support
• Reviewed database structure for consistency wif project requirements
• Executed functional tests and evaluate results to ensure accuracy and quality of complex system changes
• Provided testing feedback to technology and monitor adherence to functional requirements
• Provided input to teh study management plan throughout teh life cycle of teh study
• Provided training on technical aspects of EDC utilization and support teh client's user community in teh proper use of this technology
• Managed technical issues through logging defects in teh issue tracking tool, Seapine
• Wored closely wif teh clients to create teh study design specification, custom database export specifications, and edit check specifications
• Trial Development: Developing edit checks on EDC tools viz. Oracle - Inform and Central Designer
• Estimation: Calculating teh person days required for various activities involved in a clinical trial development
• Form Tech Review: Analyzing all teh forms/eCRFs to ensure that teh clinical trial can be hosted wifout errors/multi revisions
• Edit Check Tech Review: Analyzing all teh edit checks to ensure that logic provided for all teh checks can be coded properly
• E-room Clarifications: Communicating wif client about any clarification through E-room portal (an interface between us and teh client)
• Trial Data Extraction (TDE): Extracting data of patients from teh InForm database for various data manipulations and analysis
• Post Production Changes: Implementing changes to clinical trial post production in Oracle - Inform and Central Designer

Tools: Oracle Inform (Architect and Central Designer), SQL Toad, VB Script, and .NET