SUMMARY:

• Demonstrates technical expertise and knowledge of Information Technology standards, solutions and processes to facilitate timely resolution of business issues and requests.
• Ensures that the IT services provided are meeting the needs of the various business units.
• Lead the gathering of business needs through proactive, direct interaction with business stakeholders in understanding business processes, the key drivers and measures of success for the enterprises, and the short - term and long-term direction of the departments, the operating unit and technology.
• Manages all business unit or service line issues, projects and requests. Strong knowledge in Software Development Life Cycle.
• Possess savvy business skills as well as diplomatic communication skills.
• Recognized as an aspiring leader, innovative thinker and a trusted decision maker.

TECHNICAL SKILLS:

• Lab Techniques (Centrifugation, Titrations, pH, Wet Chemistry Techniques, Assisted Fertilization and Hatching Techniques, Pipetting, and Aseptic Manipulations)
• Computer (Microsoft Office, WebEx, Visio, Microsoft Project, Lotus, Apple iWork, Internet Explorer, Safari, Oracle, Intellivenge, SPSS, SAS, SAP, JIRA, ServiceNow, Safety Always, MATLAB, Microsoft SQL Server, Oracle Database, Net Framework, Epic, SoftLab, McKesson, Nuance, Thermo Fischer, STARLIMS, Empower 3 Chromatography, Siemens, Lawson, ADP, VMware Airwatch, Inter/Intranet Environments, Team Foundation Server, LABVANTAGE, LabStation LabWare, SharePoint, SNOMED CT)

PROFESSIONAL EXPERIENCE:

Confidential, Falls Church, VA

Business Relationship Manager

Responsibilities:

• Primary accountability is establishing, managing, and maintaining relationships with business partners.
• Leads the gathering of business needs through proactive, direct interaction with business partners in understanding business processes, the key drivers and measures of success and the short-term and long-term direction of the departments, the company, and technology.
• Spearheads a committee to create project management process and associated documentation
• Manages the development and implementation of clinical projects
• Identifies the key metrics required to enable continuous improvement of IT services and the increased customer satisfaction with IT services.
• Search for and identify sources of technology advantage and look for opportunities to anticipate and satisfy changing internal and external customer needs.
• Functions as internal consultants in developing and improving/automating business processes and productivity, applying developments in technology to business systems.
• Based on breadth and depth of understanding of business needs and processes, collaborate with Information Technology professionals to determine if solutions currently exist (internally or externally) or whether new solutions are feasible.
• Analyze and determine the operational and financial impact of new product and service offerings.
• Take a broad perspective to determine how such solutions will impact existing work processes and systems, and how to manage the integration
• Aligns Information Technology resources and processes in order to meet the client organization needs.
• Regularly communicate with the business unit(s) and champion Information Technology services.
• Ensures the Information Technology resources are providing quality service to internal members/departments of the firm as well as external clients and vendors by displaying professionalism via electronic and print correspondence, over the telephone and in-person and by encouraging an atmosphere that rewards a "can do" attitude.

Confidential, Mclean, VA

Business Analyst

Responsibilities:

• Team liaison between business analysts, project management, solution architects and development teams, and shepherd LIMS project through the design, build, and test phases
• Liaison among FDA stakeholders to elicit, analyze, communicate and validate requirements for changes to business processes, policies and laboratory information systems (LIMS)
• Managed end users, onsite support and management in regards to their understanding and the documentation of functional business requirements and clinical workflows
• Designed processes to migrate laboratory inventory from the existing inventory system(s) to LIMS
• Translated business requirements and business intelligence reporting requirements into functional/technical specification or source system analysis documents.
• Provided input from high-level to detailed estimates for intake, projects, and change requests in areas of responsibility
• Participated in the FDA’s EPLC process during successful deployment of LIMS
• Created technical impact assessments utilizing input and direction from business analyst, architects, development and supporting documentation such as functional specifications and use cases
• Performed proactive data profiling to ensure source system data requirements in the project deliverables
• Responded to ad hoc analysis requests and collaborating with test resources to validate test cases, defect triage and resolution.
• Documented and implemented test plan, test cases and test scripts
• Performed Quality Assurance testing of new and modified functionality
• Provided alternatives both to the application changing and all upstream and downstream systems, or identify if a change is a manual process taking into account the entire picture as well as the details
• Lead demonstrations and the acceptance testing process with the FDA to ensure that the changes met their needs
• Initiated and executed initiatives to improve the processes, procedures, and tools utilized by the team
• Reviewed deliverables and provides input for other analysts
• Created and delivers articulate and effective oral presentations to a variety of audiences, large or small, internal or external
• Created/updated SharePoint master pages, configures SharePoint permissions
• Coordinated with production support on system enhancements and provide ongoing operating support
• Regularly conveyed status to stakeholders and management

Confidential, Reston, VA

Healthcare IT Business Consultant

Responsibilities:

• Prepared requirements document to successfully implement customer clinical user needs and software design/standards for Veteran’s Administration Electronic Medical Record (EMR) system
• Created user stories for clinical information and clinical workflows; prepares thorough documentation of these efforts in collaboration with Marketing, R&D and Quality
• Documented clinical & logistical customer interactions (surveys, interviews, etc.) gathered through formal and informal VOC efforts.
• Utilized interfaces with User Experience Design (UXD) to ensure product specifications & design align with Confidential harmonized styles/standards and with clinical domain expectations (e.g. Physician vs. Nursing UXD)
• Utilized SAP to complete assigned deliverables.
• Utilized Team Foundational Server to complete Project planning, user story creation, requirements, task planning, and other Agile work items
• Provided clinical Subject Matter Expertise to assist Product Management with downstream Marketing activities as SME (remote customer training, remote product demonstrations).
• Established ownership of assigned product development deliverables as directed for the Project History File and the Design History File
• Remotely assist Product Management as needed in educating limited release sites of clinical relevance of LCRs: i.e. clinical / technical end-user training & feedback on the products
• As SME, assist Product Management in coordinating requirements & education w/ Global Customer Service
• Documented workflow and lead reverse engineering efforts for electronic medication administration (eMAR) systems
• Extensive knowledge with Confidential ’s commercial and Confidential medical software applications which integrates with clinical information systems (CIS)

Confidential, Rockville, MD

Healthcare IT/ Business Consultant

Responsibilities:

• Developed, implemented, and managed CareMaps/workflows for healthcare organizations in their laboratory and radiology departments
• Assigned/mapped procedures and resources (supplies, overhead, and labor) to their laboratory/radiology workflows
• Conducted data analysis of service delivery to identify unnecessary steps, properly align resources, reduce waste, standardize service delivery and establish best practices
• Provided analysis and support for clinical applications (LIMS, McKesson, Nuance) used throughout clinical departments - Laboratory and Radiology
• Prepared Go-Live and presentation materials of software applications
• Build, maintained and presented sales/demo presentations at Medical conferences, webinars, and trade shows
• Provided comprehensive implementation, data services and end user training to utilize the software solution
• Created and maintained social media channels

Sr. Research Assistant/Medical Technologist

Responsibilities:

• Function as a lead technologist or laboratory technical supervisor as assigned and training laboratory staff
• Oversaw and performed laboratory testing with the highest standard of professional performance and in accordance with established standards including: instrument start up, function checks, processing test results and quality control procedures
• Supervised and monitored the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results
• Managed problems that affect test performance or reporting of test results
• Performed specialized lab testing for cellular therapies and lab testing for the QC of cellular therapies and blood components
• Adhered to quality control procedures, including documentation, instrument and procedural calibrations and instrument maintenance
• Documented Standard Operating Procedures for the cord banking process
• Prepared a needs assessment, readiness assessment and workflow analysis to implement an Electronic Medical Records software system
• Prepared and distributed training aids such as instructional material, handouts, evaluation forms, and visual aids; sets up audiovisual equipment and make presentations
• Captured new software and hardware requirements for LIMS from end user feedback and communicate those to the software vendor
• Prepared documents for the LIMS software system
• Provided clinical support and maintenance activities for clinical interfaces such as lab and hospital interfaces
• Knowledge of cGMP, AABB, FACT and FDA regulations

Confidential, Rockville, MD

Embryologist

Responsibilities:

• Received, prepared, inseminated and performed cultivation of oocytes
• Performed manipulation techniques for assisted fertilization (ICSI) and assisted hatching
• Participated in thorough investigations into product failures using standard industry investigation tools (e.g., Root Cause Analysis, DMAIC, 5 Whys)
• Trained new hires on SOPs, GLPs, and QC/QA
• Prepared heparin media for follicular flush, culture dishes for egg retrievals, embryo transfer (ET) dishes
• Performed freezing of supernumerary embryos, thaws embryos and prepares for embryo transfer

Confidential, Morris Plains, NJ

Cell Processing Associate II - Principal Investigator

Responsibilities:

• Execute corrective actions and develops innovative ideas for process improvement
• Participate in thorough investigations into product failures using standard industry investigation tools (e.g., Root Cause Analysis, DMAIC, 5 Whys)
• Aseptic GMP manufacturing of clinical and commercial human blood therapeutics in a clean-room environment with biological safety cabinets
• Maintain standard operating procedures (SOP’s), batch records, and other applicable documentation to comply with regulatory requirements and good manufacturing practices (GMP’s)
• Assist the validation department in executing applicable protocols effecting the manufacturing equipment or environment
• Knowledge of cGMP/QSR and FDA device/drug/biologics regulations

Business Project Coordinator

Responsibilities:

• Prepared for internal global patient meeting
• Engaged internal and external audiences in global social networking initiatives
• Helped gather and support Best Practices sharing
• Coordinated capacity-building and mentoring projects for patient groups
• Aligned initiatives with clinical trial awareness strategy
• Prepared patient research initiatives through creating a software system for patients to have discussions, webinars, and provide a calendar of events