Danny Harris Email & Phone Number

Ludwigshafen, De

New York, Ny, Us

Irvine, Ca, Us

Shelton, Ct, Us

Lead Group that managed Lab Operations and its Financial Responsibilities. This included but not limited to LIMS, Ordering of Capital Equipment, Managing Budgets, Vendor Relationships.....! Requirement Gathering and Face to Face Interactions were extremely important.

Virginia Beach, Virginia, Us

Responsible for translating moderately complex and varied business needs into application software requirements. Possesses full technical knowledge of most phases of systems and business analysis and is able to consider the business implications of the application of technology to current and future business environments. Primary duties may include, but are not limited to: 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.

Durham, North Carolina, Us

Programmer/AnalystCook Programs in Server Environment through work with ProgrammerPlan and coordinate database design, development, implementation, maintenance, and user support of clinical systemsProvide technical expertise in conjunction with internal and external clientsMay interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverablesWork with INFORM Programmers to improve Database build processDaily Maintenance for Servers and Operational DatabasesSet up meetings to find ideas, new strategies, and document improvementsProcess Improvement, improve Relationship and Communication as a Liaison to DB Vendor with Quintiles, Training of Associates on SOPs and DBsCustomer Delivery Manager/Sr.Business AnalystLeading Team as Sr. Business Analyst on Various Projects (Group DB and CRM System, Reporting Tool)GAP and Budget Analysis Gathering of Requirements needed to Successfully Accomplish Goals Developed and Manage UAT Test Plan and Execution for Merge DBCreation of Training ProtocolLead on Audits for Group Meeting with Stakeholders at all LevelsProcess Improvement for CEVA (Clinical Endpoint Validation and Adjudication) including maximizing database systems within group (locating bottlenecks in Process Flow) Study Over site for DB build Improvement of Reporting Options (introduced OBIEE, CONGOS, CRYSTAL REPORTS) Improving Vendor Relationships/ Liaison within Dept for Database VendorHelp Develop Strategy Moving forward that will continue to support Drug Development and Regulatory ComplianceStrong Presentation and Communication SkillsPart of Team prepare Service Level Agreement (SLA)Help Develop Business Strategy to Improve Brand of DepartmentCompleted GCP Exam 31May2013

Reston, Virginia, Us

I am learning Provantis Database to train/advise others in Research Labs. This database specializes in handling Pathology/Toxicology. I play the role of Trainer and advisor; Writing Test Cases for Validation of Database

Morrisville, Nc, Us

Building and Updating Tables in Oracle using SQL working in PL/SQL Developer. Prepare Coding Reports for Data Managers and End Users. Document Manager Adminstrator using Microsoft VSS.

Learning Oracle ClinicalWorking with Sponsors 2ND Pass UPDATES, Discrepancy Reviews Testing Edit ChecksQC of Data

Access Database, CRF Preparation, SOP's, Software Validation, Teleform (OCR), and SQLReporting using EXCEL USED Clin Trial Database, learning and using Oracle and PL/SQL , SQL DeveloperBuild databases in Access and Clintrial/Oracle Rules, Codelist)Prepare queries for data extraction from Clintrial, Access and Oracle DatabasesLearning To Be a Study Monitor Preclinical, Laboratory and Post Marketing TrialsGxP Compliance Developed Study Monitor Report Form on ClinTrial Works closely with Customers to plan and validate database to provide best Product Handle 4-6 Projects/YearTraining Staff on how to use Novartis DatabaseSet up Database at Novartis Canadian Sites

FDA TrialsValidation of Syngenta SOPs and Product (Product Support and Regulatory Affairs)Colorimetric Assays (Customer Samples), extractions (wet chemistry), Spectrophotometer TECAN Multichannel Liquid Handler Maintenance of equipment in labOrdering of lab materialsPreparation and sending of reportsGLP Certification

Site Closing)Validation and implementation of screening procedures.High, Medium, and low throughput screens with different types of Assays.Writing of SOPs.Project Leader/Point Person of group of 3 FTE's and 1 Automation FTE.Execution and Control of Projects/Project ClosureDaily maintenance of Project by maintaining Budgets.Liquid Handlers included FLIPERS, TOPCOUNTS, VICTORS, MULTIMEKS, MULTIDROPS, ALPHAQUEST, and MAPS2nd shift Liaison for Automation and LIMS SystemGLP Certification

Site Closing)ELISA/ELCA assays in Cancer ResearchBacteria Research (implementing Bacteria DNA into PCR)Isolation of E-Coli and some Western BlotsBiotek Microplate Washer

Environmental MonitoringLAL Test, Sterility Test, Bioburden TestGLP, GMP

Us

Supervise high throughput Oligo production lab to QC oligo samplesPerkin Elmer Liquid Handler for Oligo PreparationPurify Oligos using robotic chromatographyQC using Maldi-TOF

Wrote and implement SOPs for PCRDNA/RNA DigestQC PCR material and ordered inventory

DNA/MOLECULAR LABORATORY. Writing of SOP's, Safety Standards, and Labeling of Probe Markers using Radioactive Isotopes, PCR, and STR

• Conducted PCR gene typing for individual and pregnancy identification, leading a team of 3 in vendor management and interdepartmental communication.• Implemented efficient vendor management strategies to streamline communication and prioritize cases effectively.• Achieved an increase in turnaround time for case resolutions through improved communication and collaboration.• Developed strong skills in PCR gene typing, vendor management, and interdepartmental communication.

Site Closing)DNA Testing

Mba, Pharmaceutical Business

Bs, Applied Science

Education record

Master, Information Systems