1. Karen Gallagher
Cell Phone: 904.910.4914
Email: karen.gallagher@comcast.net
1011 Gadd Road #105
Hixson, TN 37343
Overview
A highly versatile professional with over 15 years of experience with operational plan implementation, organizational
and process development, project management, life-cycle management and product management expertise. A
proven leader with excellent communication skills and the ability to conceptualize develop and implement various
solutions to previously unresolved needs and/or problems. An energetic, determined manager and team builder who
is results and growth oriented with the ability to envision the big picture and implement details.
Key Skill Summary
Product Development
Certified Agile Product Owner
Business/Functional Requirements Development
Use Case Development
Tactical And Strategic Marketing
Sales Territory Management
Lean Six Sigma Green Belt
User Documentation Design And Development
System Integration / Installation
Policy & Procedure Analysis & Development
System Test Planning And Execution
Systems Design, Configuration & Implementation
Usability And User Interface Design
Curriculum Development & Delivery
Professional Experience
BlueCross BlueShield of Tennessee
Business Analyst - Pharmacy Management
2015 to Present
- Manage Request for Proposal (RFP) database as well as prepare pharmacy responses for
client RFPs. Work with PBM on specialized reporting for RFPs such as disruption reports for
prospective clients
- Created and/or updated numerous work documents including Pharmacy Operations Manual,
Mail Order Manual for customer support, Pharmacy Product Reference Guide for sales and
account representatives
- Created fliers on new drug releases, conversation starters on clinical programs for sales as
well as marketing collateral to leave client describing clinical programs.
- Created a clinical programs competitive analysis grid of PBM offerings for sales
- Started Pharmacy Newsletter for internal distribution .
- Worked with Express Script team on pharmacy operations issues and programs under
contract. Monitored adherence to contract delivery requirements.
PaySpan Corporation
Business Analyst - New Product Development, Consumer Facing Web Applications
2014-2015
Develop requirements and business rules for new product development as well as user interface
design for provider, member and payer portals. Working on member enrollment and premium binder
monthly payments for the consumer, payment processing and partnering with state and federal
healthcare exchanges. Designed website for managing payments and other consumer features.
Designed member EOB by creating 835 from online patient payments for provider services.

2. Karen Gallagher
Availity, LLC
Product Manager/Product Owner/Business Analyst – Clinical Solutions
2007 - 2014
Developed process to create an X12 authorization transaction from an admission message in acute
care centers. The product manages observation and inpatient admissions as well as performing
inquiries for pre-admission authorizations. Created 50-80% efficiency/cost savings to the health plan
as well as increasing speed to payment for providers.
- Implemented Availity's first product entry for clinical data exchange for interoperability of HL7
health information data with other healthcare entities such as laboratories, hospitals, radiology
centers, physician office EMRs and health plans to increase productivity, efficiency and improve
revenue cycle management. First project in company using Agile development processes.
Clinical product owner and subject matter expert for other clinical teams.
- Product manager for CarePrescribe product release into the Availity portal. Application provides
both web and hand held “fully informed” e-prescribing solution deployed in Florida and Texas to
help reduce prescription errors. Developed all utilization reporting to monitor prescriber formulary
and patient safety compliance
- Product manager of a payer claims based health record which can be displayed on a web portal
or B2B. Redesigned user interface, application code update. Added new features to product to
increase utilization and adoption.
- Managed numerous other projects like claims reconciliation tool, real time claims adjudication
from a member cost estimator, 835 registration and delivery, provider data management and
product registration. Used SalesForce to manage change requests.
- Worked on multiple projects with 30 Blues plans, Humana, Cigna and Aetna.
Roche Diagnostics
Senior Consultant, Healthcare Solutions 2005 - 2006
- As a team member, projects included consulting services to healthcare facilities in the areas of
Lean Six Sigma, Change Leadership, Project Management, Activity Based Costing, Lab Design,
Outreach Business Development and IT services all projects designed to reduce c9osts and
improve efficiency and productivity.. Primary customers are Clinical Laboratories and Process
Improvement Teams within Hospital Facilities
- Six Sigma Green Belt and Lean Practitioner
- Authored three magazine articles on Lean Six Sigma in Healthcare, Activity Based Costing,
Selecting a Consulting Service. Developed Sales collateral in the form of case studies on all
areas of services provided
Shands Jacksonville
11-7 Shift Supervisor 2003 - 2005
− Manage Core Lab department
− Investigate panic values, delta check and accuracy of patient and QC results. Initiate action plans and
corrective action. Review/audit patient data and quality assurance program for compliance to lab
policies.
− Set schedules, hiring, employee training, performance reviews for all shift employees
− Key member of Laboratory Information System Implementation team of new MYSIS/Sunquest system
− Developed web based SOP system, rewrote and developed SOPs for greater accessibility by
employees
Cetan Technologies, Inc.
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3. Karen Gallagher
Director of Marketing Services 2001 – 2002
− Reestablished the marketing department by developing both tactical and strategic marketing
plans including a name branding campaign. Prepare marketing research for new products and
market opportunities for pharmaceutical, biotech and medical device industry. Company provided
expertise to companies related to FDA regulatory compliance issues.
− The corporate website was revitalized which increased traffic and sales leads. Served as web
mistress for the company and was responsible for writing all content and design aspects of the
site. Updated all sales collateral for both web downloads and printed media.
− Developed a leads tracking and accountability system until the selection of a CRM system was
completed. Increased Sales tools development to support the sales team. Sales tools such as
proof sources, case studies, testimonials, white papers, press releases, etc. increased sales
effectiveness as well as the development of a sales training program.
− Selected and coordinated all trade show events, show giveaways, advertising, booth design and
marketing opportunities. By increasing the company’s trade show presence to more targeted
events, it has resulted in over $2M of new business due to better-qualified prospects.
DynaMedix Corporation
Director of Quality Assurance 1995 - 2000
Software Product/Project Manager
Director of Customer Training
− Established and managed a corporate Quality Assurance department. The establishment of
quality processes enabled the company to be compliant with FDA/GMP 21 CFR part 11 and ISO-
9001 requirements. Implemented methods to monitor quality improvements such as the addition
of defect tracking software, audits, project planning tools and methods and production processes.
Performed all product investigations and developed action plans. Managed software testing team
for all products launches. Developed test protocols and processes to achieve product readiness.
− Established a new customer training and support center. Located office space, wrote policies and
procedures, hired and trained new staff. Implemented an automated call distribution phone
system and call management software package, which resulted in the ability to track customer
history and improve satisfaction. Developed self-paced customer training programs for both
classroom and on-site installations. Coordinated on-site system implementations, scheduled
personnel and managed phone support. Performed system installations at customer sites.
Helped design new interfaces for various clinical instrumentation to link into hospital information
and EMR systems. Developed all user guides and help content.
− Product Manager for the PocketCode market release that provided Pocket PC handheld
technology for physician’s offices. Led the team in defining product features, user interfaces,
manufacturing processes and QA software testing efforts. Developed multi-user, networked,
wireless version. Created product branding, market research, advertising, marketing direction and
applied for all trademarks. The effort resulted in the expansion of a new product segment with a
total available market of over 250K of potential users. Trained sales reps, developed sales
collateral and helped formulate sales programs. Also trained support staff and customers on
Pocket PC and PocketCode software.
− Product Manager for all software product releases to existing customers for multi-user,
client/server systems for clinical laboratories. Developed all requirements, selected team,
managed project, quality assurance, manufacturing and product rollout plans. Ensured that all
staff was trained to manage field upgrades. Developed and executed black box, regression and
system test protocols. Selected customer test sites and oversaw pre-launch product testing.
Validated all manufacturing processes.
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4. Karen Gallagher
Abbott Laboratories
Technical Product Development Manager 1986 -1995
Customer Training and Support Systems Analyst
− Managed numerous software releases into production, on time and on budget. Planned and implemented all
software upgrade processes and retrofit budgets. Completed Abbott Project Management training
curriculum. Team managed all software testing including stress, regression and user testing scenarios.
Responsible for ensuring that all FDA/GMP and corporate quality standards and objectives are met for each
project. Managed onsite clinical laboratory used in software development process. Product was data
management systems for clinical laboratories.
− Represented Dallas Business Unit as site representative to ISO-9001 certification process. Implemented
and maintained processes and procedures necessary to be certified as a member of the site team. This
resulted in site certification, meeting the company’s objectives to comply with European regulatory
requirements.
− Organized and led Lab Data Management team, which consisted of multi-discipline areas including support,
training, worldwide field service, purchasing, IT, materials management, site QA and QA testing team.
Responsible for coordinating all Dallas project activities with Chicago business unit to insure on time product
delivery and launch readiness. The Dallas team met all of its objectives/time lines and successfully launched
the product.
− Improved first line technical support by becoming a lead problem solver for the data management product
line. Conducted all sales training, technical support training, field service training as well as new employee
training on the products. By serving this role, it enabled the first line support staff to have a resource to
answer questions for customers and sales staff thus improving customer satisfaction. Developed User
manuals and help screen text.
− Performed system implementations in the field (both data management and instrumentation) and provided
training both in-house and on-site. Set up process for investigating problems that arose in the field and
communicating resolution to customer and staff. Developed procedures for managing vendor/subcontractor
quality.
− Responsible for hiring, coaching, performance reviews and career development. Developed all yearly
budgets including strategic and tactical planning for new product development and system upgrades.
− Received various awards and recognition for Technical Excellence and Support.
− Promoted at Availity to clinical team leader/SME and Product Owner III
− Have worked as a medical technologist at numerous laboratories in an part time capacity.
Education
B.A. – Biology and Chemistry – Pfeiffer University
Emory University School of Medical Technology
MT(ASCP) Certification, Medical Technologist, American Society of Clinical Pathologists,
Florida MT license # TN38027
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