SUMMARY

• Over 12+ years of rich, end - to-end Business Analysis experience in the IT and Life Sciences - Pharma / Medical Device domain
• An accomplished, results-oriented Technical Functional Business Analyst with 9+ years of experience directing large scale projects.
• Subject Matter Expert (SME), bringing in deep consulting and technology expertise in clinical systems & data management
• Delivered excellent customer service and gained respect of client management and end-users
• Experienced IT business analyst who has successfully led large project teams from requirements-gathering through to implementation and support
• Successfully demonstrated Leadership skills and project management skills in the roles of Project Manager
• Domain experience within Pharmaceutical/Medical Device Clinical Trials development and data collection, Healthcare or Medical
• Familiar with current industry standards and involved in all phases of SDLC for SOX, Title 21 CFR Part 11 and validated applications.
• Competent technical guru with 10 years of hands-on database programming and in Relational Database (Oracle)
• Experience in Data Analysis, Data Modeling, Data Mapping using SQL and UML diagrams
• Excel in client relationship management; for more than 10 years have worked in client facing roles to identify requirements, provide cost analysis and develop deliverables in given time.
• Contributed to RFPs, Business proposals, presentations and estimates
• Excellent communication skills coupled with excellent interpersonal skills
• Strong Experience with Agile development methodologies and techniques.
• Strong vision of achieving successful outcomes for clients and partners.

TECHNICAL SKILLS

Operating Systems: Windows Platforms

Programming Languages: C, PL/SQL, SQL, Unix Shell Scripting

Database: Oracle 10g/11g

Tools: PL/SQL Developer, LSH

Reporting Tool: Spotfire, Tableau, Business Objects 3.0

Microsoft Technologies: VSS, MPP, Visio, VB, VB Script

Electronic Data Capture (EDC): OutComeLogix, Oracle Clinical, InForm 4.6, Clintrial 4.5, RAVE

Clinical Data Standards: CDISC, SDTM, SDTMIG, ADaMs

PROFESSIONAL EXPERIENCE

Clinical IT Business Analyst

Confidential

Responsibilities:

• Subject Matter Expert in Post Approval Network group of Confidential to provide analytic solutions.
• A “Go-To” person for all reporting and compensation needs for the business.
• Strong problem-solver who can design solutions and assist developers with issues
• Consistently drove business process improvement through the development of new strategies
• Developed reports to compare budget and actual results for use by business managers in the field
• Managed all aspects of composition of business analyst documentation including As-Is/To-Be process flows, requirement specifications, business rules, functional requirements and uses cases.
• Lead projects to provide current state documentation and facilitate changes resulting from project outcomes
• Conduct meetings with business owners / stakeholders / application owners / subject matter experts to ensure understanding of current state of the system.
• Identify gaps and conflicts between business needs and configuration or system capabilities
• Analyzing existing customer satisfaction functionality requests for providing business-value based recommendations to Product Owners
• Segregating business needs into small components which can then be individually tackled to provide an optimal solution.
• Facilitate brainstorming and document results
• Facilitating requirement, root cause analysis and other requirements workshops
• Conducting requirements training sessions and developing best practices for product delivery

Clinical Data Migration - Lead

Confidential

Responsibilities:

• Develop and use enterprise service and data models
• Prepare data migration plans including migration risk, milestones, quality and business sign-off details.
• Designing and creation of the technical specifications to support the development of reports,
• Understanding reporting objectives, gathering data requirements, responsible for defining detailed requirements, analyzing business needs, and validating solutions
• Detailing requirements through report development and other reporting solutions to support the project team, Configuring highly complex components based on functional requirements
• Provide technology direction to business for tactical approaches
• Relational Database experience such as with Oracle or SQL Server. Experience in Data Analysis, Data Modeling, Data Mapping using SQL and UML diagrams
• Responsible for handling the Legacy Corporate Data warehouse and Multiple DataMarts.
• Responsible for analyzing the data flow from Source system/Upstream Application to Warehouse and subsequent downstream application.
• Manage the load, transfer and conforming in the Oracle LSH data warehouse and the provision of clinical data extracts to Clinical Data Consumers
• Develop and maintain Operational Clinical Data Stores, data marts, Reporting and Regulatory Submission report as it relates to systems and data information provision
• Work across multiple functional projects to understand data usage and implications for data migration..

Clinical Database Programmer /Modeler Lead

Confidential

Responsibilities:

• Provide guidance and direction on data warehouse modeling best practices and procedures
• Data Modeling Subject Matter Expert (SME) to Development teams.
• Modify, install and prepare technical documentation for Data Modeling tools
• Monitor physical data structures and ensure adherence to conceptual and logical data models
• Create and maintain data inventory, data dictionaries and metadata for Standard data structures
• Create and maintain data models (conceptual, logical, physical) and ensure data models adhere to published development and architectural standards
• Create indexes to optimize database read/write performance
• Ensure ETL solutions conform to source to target mappings and data transformation rules through periodic code reviews
• Relational Database experience such as with Oracle or SQL Server. Experience in Data Analysis, Data Modeling, Data Mapping using SQL and UML diagrams performing SQL tuning using Explain Plan, Tkprof, Hints and indexes.
• Participate in architecture and design activities to ensure data model and detailed design developed is in line with business needs

IT Project Manager

Confidential, Santa Clara, CA

Responsibilities:

• Work with Clinical Business partners to understand the requirement and recommending suggestions, eliminating gaps
• Oversee the design, development, validation and implementation of IT Applications/Systems
• Manage Study Setup projects (design and development of EDC studies) in InForm and RAVE
• Manage EDC Integration projects - Safety Reports, Inventory Reports, Clinical Data Repository, Site Payments, IxRS, Adverse Event Reporting.
• Work with different Clinical & IT groups - Data Management, Safety, Product Performance Group, Clinical Operations, IT Process & Compliance, DBA
• Project and plan resources. Prepare resource projection to senior management based on projects in pipeline
• Developing project plans, goals, and budgets; identifying resources needed
• Recording and managing project issues and escalating where necessary.
• Work on Process improvement and efficiency
• Work with business on IT Roadmap and plan according to business & IT needs.
• Work with Process & Compliance in developing process documents (SOP, DOP)
• Manage Scope, Budget, Schedule, Quality and Risk of projects
• Resolving cross-functional issues at project level.
• Monitoring project progress and performance.
• Providing status reports to the project sponsor.
• Manage of the User Acceptance Testing program.
• Organizing and managing all phases of the project to ensure on-time completion

Clinical Trial Analyst Lead

Confidential, Swift water, PA

Responsibilities:

• Database design specification in consultation with Data Management, Clinical and Statistical Programming, Clinical Coding, and Safety
• Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports
• Conduct training on EDC database use to support internal users
• As SME is responsible to provide escalation of study specific functional issues, application/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting
• Support development and review of SOPs, and Work Guidelines to promote consistency
• Identify additional opportunities for standardization and departmental efficiency
• Ensure compliance with eClinical and industry quality standards, guidelines and procedures
• Lead the effort of Process/Standards development and implementation including best practices to improve quality and streamline database build and data cleaning efforts
• Coordinate Offshore activities for trial build and QA.
• Have participated in building Testing Strategies and documented Validation Master Plans (VMP) for development projects.

Clinical Database Programmer Lead

Confidential, Jersey City, NJ

Responsibilities:

• Validate and design programming specifications of EDC (Electronic Data Capture)
• Develop configuration of EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reporting
• Implement and perform data integrations related activities to ensure data integrations meet client requirements
• Advise clients on best practices for clinical database builds, eCRF layout, compliance with CDISC standards
• Ensure data can be extracted easily from the back-end to support efficient downstream reporting and analysis
• Consulting efforts related to EDC systems including UAT, global library/standards development
• Coordinate with offshore team - provide technical & general leadership