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Business Technology Architect Resume

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East Hanover, NJ

SUMMARY:

Senior IT specialist with team leading experience as well as self - starting drive and ambition for challenges; an exceptional problem solver who is self-motivated, hard-working, efficient and detail-oriented, who works well independently and as part of a team, works well under pressure, learns quickly, and is a natural leader.

SKILLS:

Expertise in: Excel, SharePoint, BluePrint and RTC - proficiency in MS Word, Access, Visio, Publisher, Front Page and PowerPoint - experience with Photoshop, Adobe Acrobat, QA software, data entry software, SAS, SQL, Google Analytics, Microstrategy, Cognos, AWS, BPMN, Aspera, Intralinks, HTML, Linux, Visual Basic macros, SPARC, Prosit, IMPACT, Rave, dBox, SPECTRUM, MIDAS, Inform EDC, STREAM and PRIMA, Axure, iRise, Appian, Tibco, Nintex, Argus, Pega-systems, Drools, JIRA, Boomi. Excellent understanding of Pharmaceutical QC operations, GxPs, and 21 CFR Part 11.

EXPERIENCE:

Confidential, East Hanover, NJ

Business Technology Architect

Responsibilities:

  • Developed cradle-to-grave SDLC process for the Data Hub global initiative
  • Functional lead for system integrations (CTMS, EDC, EDMS, Analytic Platform, etc…)
  • Develop Change Management Process for Data Hub Program
  • Support of Boomi integration hub architecture and development
  • Managed and led team of technical and non-technical resources in the planning, design and development of the Hub Portal front-end and back-end solution

Confidential, Branchburg, NJ

IT Project Manager and Data Analyst

Responsibilities:

  • IT Project Manager and Data Analyst on ILUM program: leveraging big data to assist in driving clinical decision support in hospital settings
  • Master Data Management (MDM)
  • Develop Change Management Process for AMS Program
  • Provide strategic guidance and leadership for IT Strategy and Governance, Project Execution and Process Management
  • Relationship manager between Confidential and Lockheed Martin

Confidential, Whitehouse Station, NJ

Senior Business Analyst, Business Architect, Product Manager

Responsibilities:

  • Lead BA on Partner Engagement Lifecycle Management workstream of External Partner Portal Program (use of Agile and Waterfall methodologies for iterative/sequential processes/release cycles)
  • Product software implementation: application development, package implementation, infrastructure and transformation
  • Business Analyst on Analytic Platform (big data) - Health Data Exchange (HDEx): leveraging big data from clinical trials to drive advanced modeling and global analytics
  • Provide strategic guidance and leadership for IT Strategy and Governance, Project Execution and Process Management
  • Business Architect for External Partner Portal Entitlements Project using Appian, Nintex workflow, Tibco and Drools
  • Business Process Management, Business Process Modeling, Business Process Mapping, Business Process Flows
  • Design and build of BPM solution for global entitlements
  • Design and build of BPM solution for Clinical Provisioning
  • Design and build of BPM solution for Clinical Operations
  • Design and build of BPM solution for Investigator Sponsored Studies
  • Design and build of BPM solution for Research Grant Submission
  • Extensive Experience with BluePrint Requirements Center Software - use case, business process diagram and requirement creation
  • Production release lead, Stress Testing, Scalability Testing, Load Testing, Smoke Testing
  • Delivery of Functional Requirement Specifications and other SDLC documentation
  • Management of junior and mid-level Business Analyst resources/deliverables
  • Coordination of junior and mid-level Business Analyst BluePrint activities
  • Training of junior and mid-level business analyst in use case methodology and requirement gathering
  • Product Manager of Large Data Transfer technology and Web Application
  • Responsible for Business Impact Analysis and Disaster Recovery Analysis
  • Oversee cradle-to-grave development and implementation of 360 degree portal service for all of Merck’s external partners
  • Delivery of architectural design and vision objectives to senior management
  • Responsible for Business Process Management, development of tools, tasks and processes as well as GANTT chart management
  • Development and delivery of reporting metrics and analytics
  • Requirements gathering and all associated documentation - Requirements Specifications, Configuration Specifications and Design Specifications
  • Leverage a risk based approach to System Development Lifecycle and Documentation
  • Master data management and delivery of data solutions including SAS, SQL and R
  • Database technologies for Oracle, SQL and R
  • Created Business Process Models, Activity Diagrams and Use Cases
  • Logical Level Data Models and database designs
  • Manage Change Requests, Change Management and Training Development
  • Experience with COTS and Web-based systems, requirements, design and development
  • Functional Knowledge of Regulatory Compliance and Validation (HAR and non-HAR), SDLC, Requirements Management and UAT leadership
  • Experience with visualization software (iRise, Axure)
  • Responsible for Project Management, Financial Management, Project Task Management, Presentations at Program and Project levels
  • Strong relationship with development team and vendors

Confidential, Pine Brook, NJ

Clinical Business Analyst, Solution Architect

Responsibilities:

  • SharePoint Business Expert
  • SharePoint Process Development and Deployment
  • Packaging Configurations and Global Serialization Requirements
  • Provide strategic guidance and leadership for IT Strategy and Governance, Project Execution and Process Management
  • Use of visualization software (iRise)
  • Management of Functional Requirements in BluePrint technologies
  • Solution Architecture of interfaces and APIs - BPM tool experience - Pega
  • Leveraged CTMS Expertise (IMPACT)
  • Designed EDC and CRO Interfaces (Inform 5.5 EDC)
  • Responsible for CAPAs and gap analysis
  • Responsible for Project Management and Vendor Selection
  • Created User Requirement Specifications and Solutions Requirements, Business Process Design and Risk Assessments, Argus
  • Oversee Account Management and User Administration
  • Responsible for User Acceptance Testing and System Testing
  • Responsible for Functional Specifications and Change Requests
  • Managed the development, testing, and release of 21 CFR Part 11 compliant software platforms. Responsible for Validation Planning, Installation Qualifications, Operational Qualifications, Performance Qualifications.
  • Data warehousing, data storage
  • Created Reports (Business Objects and MicroStrategy)
  • Creation and maintenance of Reference Code and Configuration Specifications
  • Ensured that System Alerts were automated from CTMS processes
  • Implementation of IAM PRIMA System (user groups/on-boarding/off-boarding)
  • Implementation of STREAM and STREAM/IMPACT/dBox Interfaces (Funding for Investigator Sponsored Studies)
  • Implementation and Delivery team member for Investigator Portal

Confidential, Ardsley, NY

Lead Business Analyst, Application Manager

Responsibilities:

  • Responsible for SharePoint Development
  • GMP and GCP experience
  • CTMS implementation (Trial Works/Impact)
  • Responsible for EDC and IRT administration (Inform 5.5 EDC)
  • Management and Administration of Trial Works, Impact and Inform
  • Creation of Central Records Reports and ongoing maintenance, Interface with Clinicaltrials.gov
  • Responsible for CRO and Vendor selection and management

Confidential, Kenilworth, NJ

Senior Business Analyst

Responsibilities:

  • Resource planning tools and processes
  • Development, execution, maintenance, and refinement of global resource planning activities across multiple roles within Global Clinical Development
  • Liaise with Functional Areas, MRL Finance, and Project & Pipeline Management (PPM) on annual Profit Plan and ad hoc scenario forecasting requests
  • Provide operational and logistical support to GCTO Functional areas and Country Operations to ensure global consistency as related to Headquarters & Regional resource planning
  • Vendor Management and Vendor Qualification Reports
  • Creation and Maintenance of SharePoint Collaboration and Website for GCTO
  • Reporting and Analysis of Quarterly Safety Reports and Annual Safety Reports, Argus
  • Maintenance of Global Clinical Trial Operations & IB/SUSAR Intralinks Workspaces
  • Creation and Maintenance of IIS/Phase IV Safety Reporting Intralinks Workspace
  • Six Sigma/Lean Experience

Confidential, Kenilworth, NJ

Clinical Business Analyst

Responsibilities:

  • Secure Document Exchange of Clinical Trial Documents, SharePoint website maintenance
  • Intralinks expertise - management and administration of SP instance of IL
  • Access Database management, pivot tables and spreadsheet macros
  • Electronic Document Request Forms and Electronic Data Capture
  • Development of Global Website as Global Clinical Trial Management Webmaster

Confidential, Rochelle Park, NJ

Business Analyst

Responsibilities:

  • Responsible for the requirements and modification of SAS programs which required experience with SQL, Oracle and auditing techniques
  • Trained in QA/data entry (CRF review, book case review, data listings and queries)
  • Responsible for enrollment tracking, query resolution, management of AEs/SAEs

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