SUMMARY

Extensive People skills within Industry, with a strong Quality and Validation Background in Science and IT, Strong drive for success, Looking for Great Fit within Leadership Role: Goal - oriented and Results driven with great communication skills; 17 years of Pharmaceutical and Biotech Experiences

SKILL SUMMARY

COMPUTER SKILLS: Windows Environment (IE, Excel, Word), Server Environment, PC hardware/Installation, Software Installation, Ethernet, Clin Trial, ACCESS (Certification), SQL, and MySQL, learning PL-SQL, QC of Packages/Procedures in Oracle 9g, 10g, SQL Developer, PL/SQL Developer, and Exposure to TOAD and SQL Server, EDC Systems INFORM and RAVE; Teleform (CRF Data Capture software), Citrix, UNIX

SCIENCE SKILLS: Laboratory Operations, Pharma/Biotech Lab Experience, QC/QA Experience, Monitoring Experience, polymerase chain reaction (PCR), High-performance liquid chromatography (HPLC), Spectrophotometer, Liquid Handling, Maldi-TOF, assay development, screening operations, DNA/RNA isolation, LIMS System Experience, Radio Labeled Probes, SOPs

OTHER: GXP Certification (GLP/GMP), Process Improvement, Project Management Training Program, manage and develop lab budgets, strong customer service skills, document validation and control, and writing of SOPs, Audits, 21 CFR Part 11, Familiar with HL7 Standards, Clinical Experience (8 yrs), Database Validation, Training of Scientist/Medical Staffs/Employees on Databases (generate report), Developed Training Protocol, Minitab, solid Accounting/Financial understanding based on MBA, Worked with Product Development Management Team, Worked with Customers in the Field (in house CRM), Heavy Presentation and Communication Skills; Business Strategy Ideas within Systems Environment

PROFESSIONAL EXPERIENCE

Business Consultant 

Confidential

• May lead teams of analysts assigned to complex projects
• Determines specific business application software requirements to address complex and varied business needs
• Analyzes and designs solutions to address complex and varied business needs
• Consults with business partners concerning application and implementation of technology
• Act as a Senior Business Analyst
• Act as a Liaison between Departments
• Lead on larger projects and or multiple projects at a given time
• Knowledge of process within the infrastructure of the company
• Working on providing Reports as my main focus for the Global End User
• Work with the Business Owners on budgets, timelines, and resources
• Use of SDLC Software build in house to track movement of Projects
• We use JIRA exclusively in an Agile Environment
• Use SDLC Tool to follow process of Project
• Gathering and writing of Requirements for BRDs
• Agile Working Environment and Training
• SaaS and or Data Driven environment

Associate Customer Delivery Manager/Sr. Business Analyst

Confidential

• Leading Team as Business Analyst on Various Projects (Group DB and CRM System, Reporting Tool)
• Risk Management for Group (bottlenecks, resources, process improvements)
• GAP and Budget Analysis
• Gathering of Requirements needed to Successfully Accomplish Goals
• Developed and Manage UAT Test Plan and Execution for Merge DB
• Creation of Training Protocol, working on SharePoint
• Lead on IT Audits for Group
• Meeting and Establishing Relationships with Key Stakeholders at all Levels
• Process Improvement for CEVA (Clinical Endpoint Validation and Adjudication) including maximizing database systems within group
• Study Over site for DB build
• Improvement of Reporting Options (introduced OBIEE, CONGOS, CRYSTAL REPORTS)
• Improving Vendor Relationships/ Liaison within Dept for Database Vendor
• Help Develop Strategy Moving forward that will continue to support Drug Development and Regulatory Compliance
• Part of team that improved group’s net earnings
• Strong Presentation and Communication Skills
• Part of Team prepare Service Level Agreement (SLA)
• Help Develop Business Strategy to Improve Brand of Department
• Completed GCP Exam 31May2013

Programmer/Analyst 

• Cook Programs in Server Environment through work with Programmer
• Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems
• Part time ADMINISTRATOR for INFORM DB accounts
• Provide technical expertise in conjunction with internal and external clients
• Interact w/corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables
• Work with INFORM Programmers to improve Database build process
• Daily Maintenance for Servers/ODBC usage and Operational Databases
• Set up meetings to find ideas, new strategies, and document improvements
• Process Improvement Team

Liaison 

Confidential

• Consultant/Liaison Role (Requirements Gathering) for Vistronix as a Contact for Clinical Labs using Company’s Products (databases/software)
• Collect Information from end-users for upgrade to Company’s Database System and software
• Use creative and innovative ways to train Scientist on how to use new Databases
• Lead on Validation including showing resourcefulness in writing of Test Cases (Performance Qualification)
• Assist with Project Management Oversight for Project
• Help Develop Strategy for Validation Project
• Working with Software Vendor Representatives
• Backup Administrator for Provantis Database
• Business Objects Reporting Tool used in Provantis
• Government Contract/Agile Work Environment
• Help group of Scientist and IT Personnel to accomplish Aggressive Project Goals under deadline and budget

Clinical Data Analyst 

Confidential 

• Preparation of Reports for Data Managers/SAS Programmers/Customers
• Liaison between Data Managers and SAS Group
• Building and Updating Tables in Oracle using SQL code working in PL/SQL Developer
• Complex Queries using SQL
• Use of Clinical Databases INFORM and RAVE
• Exposure to COGNOS
• VSS Administrator for Document Control (supply user rights/accounts/ issues)
• Exposure to Software Development Lifecycle

Clinical Data Manager

Confidential Cary, NC

• Oracle Clinical
• Working with Sponsors (taking information from Meetings to use in Development)
• 2ND Pass UPDATES, Discrepancy Reviews
• Testing Edit Checks
• QC of Data

Clinical Database Manager

Confidential Greensboro, NC

• Completed Task to set up Database System at Canadian location under timeline
• Access Database, CRF Preparation, SOP’s, Software Installation and Validation, Teleform (OCR), and SQL
• Gather, validate and document data requirements down to the column level, in direct support of Project Managers
• Prepared Reports in Access using EXCEL
• USED Clin Trial, learning and using Oracle 9 and 10g, PL/SQL, SQL Developer and Exposure to Toad
• Build databases in Access and Clin Trial/Oracle Rules, Code list
• Prepare queries for data extraction from Clin Trial, Access and Oracle Databases
• Prepare Reports in Clin Trial Databases
• Preclinical, Laboratory and Post Marketing Trials
• GxP Compliance/ Worked with FDA to prepare the best possible PROTOCOL
• Developed Study Monitor Report Form on Clin Trial (help to reduce time for CRA’s)
• Works closely with Customers to plan and validate database to provide best Product
• Implement Novartis Databases at New Sites for CRAs
• Training Staff on how to use Novartis Database
• Has worked with Marketing to set up Post Marketing Study
• Worked on Committee to set up Safety Database
• SAP Exposure

Scientist 

Confidential  Triangle Park, Raleigh, NC

• QC/Development Laboratory of Product
• FDA Trials
• Validation of Syngenta SOPs and Product (Product Support and Regulatory Affairs)
• Colorimetric Assays (Customer Samples), extractions (wet chemistry), Spectrophotometer
• Maintenance of equipment in lab (Includes SOPs/Revisions/Updates)
• Ordering of lab materials (maintaining budget)
• Worked with Customers in the Field
• Worked with Product Development Management Team

Associate Biochemist

Confidential,  Triangle Park, Raleigh, NC

• Validation and implementation of screening procedures/ Writing of SOPs
• High, Medium, and low throughput screens with different types of Assays
• Project Leader/Point Person of group of 3 FTE’s and 1 Automation FTE
• Execution and Control of Projects/Project Closure
• Liquid Handlers included FLIPERS, TOPCOUNTS, VICTORS, MULTIMEKS, MULTIDROPS, ALPHAQUEST, and MAPS
• 2nd shift Liaison for Automation and LIMS System

Research Associate 

Confidential Winston Salem, NC (Site Closing)

• ELISA/ELCA assays in Cancer Research
• Bacteria Research (implementing Bacteria DNA into PCR)

QC Scientist 

Confidential Sanford, NC

• Environmental Monitoring
• LAL Test, Sterility Test, Bioburden Test, GLP, GMP

Confidential High Point, NC

• Supervise high throughput Oligo production lab for QC Oligo samples
• Met Production Numbers