KAREN J. GRANITZ

**** *’Bannon Creek Lane

Loveland, Ohio 45140

Home: 513-***-****

Cell: 513-***-****

advk1r@r.postjobfree.com

OBJECTIVE To become a meaningful part of a success oriented team where I can use my

organizational, technical, and interpersonal skills in an environment that encourages

skill development, values teamwork, and demonstrates a commitment to excellence.

TECHNICAL Twenty years experience in Study Management, utilizing GSMS, WTDS, and Sharepoint

SKILLS data management systems in Central Product Safety (PS&RA) for Clinical, Non-Clinical, Internal and Environmental studies, Oracle Clinical Database for Clinical Data Management in Pharmaceuticals (Global Library DVGs, Questions, Questions Groups, Lab Test Conversion Dictionary, Investigators and Sites, Institutes), Trial Tracker (Investigators/Sites), CDISC/SDTM conversion, and management of WHO Drug files (World Health Organization). Fluent in Microsoft Office Excel, Word, and Outlook as well as Communicator/IM. Excellent work process documentation, integration, and communication skills.

EXPERIENCE:

Procter & Gamble Product Safety Jul 2011 – September 2020

& Regulatory Affairs / Central Product Safety

Adecco Assignment: Clinical Database Specialist

Provide support for final report preparation by creating new report from the signed Protocol, utilizing charts, graphs, and spreadsheets to create tables for inclusion into the final report, track reviewer comments, and updating report as required. Responsible for Clinical Draft and Final Report process by monitoring the Global Inbox for new Clinical drafts, processing DRRNs, follow up with outstanding reviews, collate comments, authorize finalization, and archive final reports. Responsible for Clairol Studies project by registering/archiving/processing Cintas inventory spreadsheet. Register and archive Supplier Reports.

Procter & Gamble Pharmaceuticals Mar 1999 – Sep 2010

Adecco Assignment: Oracle Clinical Global Library Administrator

Maintenance of Master Investigator and Site File: Clean up and maintenance of all known investigators and sites master file from Recorder and Oracle Clinical, using format dictated by OC technical and Global Data Standards guidelines. Revision and maintenance of Country Code master file and incorporation of 3-digit code standard into Oracle Clinical and Master Investigator & Site file. Monitor addition of any new Investigators & Sites into Master file posted to Data Standards Shared Drive. Global Library Change Requests: Data entry of DVG, Question, Question Group, Lab Test Conversion, Lab Site, or Investigator & Site change request into Oracle Clinical Production, Development and Test Instances. Run Question Attribute Comparison Report to check for errors – resolve discrepancies. Keep hard-copy and electronic file of all change requests. Enter change request information into appropriate Change Request Log on Data Standards Shared Drive. If change request required detailed discussion and correspondence, indicate specifics in Global Library Discussion & Resolution Log. Receive and manage quarterly updates from World Health Organization, performing drug searches as required. Update the OC Global Library Entry Guidelines documentation upon changes or corrections to the process. Help to maintain the Question Attribute and DVG & Contents Worksheets as needed. Update the Entity Relationship Diagrams for OC merges added to SAS and designations of primary and merge keys. Assist in compilation and consistency check of OCUG survey responses.

Adecco Assignment: Computer Specialist

Assist in the Data Standards Sub-Team of the IROC Project by taking and transcribing minutes from weekly meetings and posting them to the Oracle Clinical Website. Responsible for creating and maintaining Excel spreadsheets of DVG Codelists for Pilot and Production versions for OC. Assist in the downloading of CDISC website data, revising CDISC data, sample, and assumption files, and repost new files to website. Create new Change Request Forms and SOPs (Standard Operating Procedures) based upon the new Oracle Clinical Standards and using old Recorder files as a guide. Forms were created using Word and Excel, incorporating drop-down boxes, reference codelists, text boxes, table of contents, etc. Help in maintaining the OC Question Attribute Worksheet. Produce Reference Codelist Content Reports utilizing Oracle Clinical.

Adecco Assignment: Executive Committee Secretary

Participated in establishing the abstract publicity and printing process in conjunction with other team members. Mapped out process to number, edit, & track abstracts. Established requirements to meet Documentum capabilities including format and file structure set-up. Supervised data entry of Excel tracking spreadsheet & monitored accuracy. Established timeline for preparation & delivery of supplemental documents & monitored progress. Assisted Promotion Chair in producing much of the promotion copy, utilizing Word and Power Point to create business cards, slides, flyers, camera-ready announcements, call for papers, & ads for C&EN. Coordinated process to acquire Central Region mailing lists from National ACS, preparing correspondence, printing & mailing. Assisted Regional Awards Chair, in preparing correspondence & awards program brochure. Provided support in initial process of creating & preparing vendor exhibit contract, coordinating process with the Covington Convention Center. Attended monthly committee meetings as required.

Adecco Assignment: Global Perfume Lab Assistant

Manipulated large quantities of files to investigate perfume shelf life for inclusion into excel spreadsheet. Create inventory sheet, initial data entry of 400, then monthly upkeep thereafter. Search documentation for perfumer name for over 2000 materials and enter into spreadsheet. Open material shipments, check for appropriate paperwork, and enter material specs into spreadsheet. Pour 24-30 sets of 12 bottles of perfume raw material, label each bottle, mark with appropriate hazardous/flammable material rating, type orders for shipment and address labels for entire shipment, packed boxes for shipment using correct packing material based on hazard rating, and make copies of paperwork to be included in each shipment.

LensCrafters/Luxottica Dec 1994 - Jan 1999

Luxottica Assignment: Quality Review Supervisor

Reported to MD/Executive V.P., EyeMed Vision Care. Responsible for credentialing of subleasing, employed, & augmented doctors affiliated with LensCrafters. Utilize AS400 mainframe, Lotus, & Sweet Q databases to monitor credentialing & third party provider agreement status of doctors. Track doctor phone #’s, locations, classifications, & services provided, & inform all key personnel of any changes/additions. Handle doctor questions/ concerns. Design & prepare correspondence detailing processes & protocols. Manage SweetQ/AS400/Lotus database conversion and integration in conjunction with Information System’s support personnel. Utilize Power Point for use in process planning & management. Provide administrative support to V.P. as required.

LensCrafters Assignment: Administrative Assistant

Reported to AVP of Construction. Maintain the Store Opening Report database & distribute weekly detailed reports. Maintain & distribute weekly Real Estate Log, tracking release of new/relocated stores, assign store numbers, monitor receipt of tenant criteria, assign resources, & forward to Planner and to Team. Maintain the store number master file. Prepare quarterly Customer Satisfaction report on detail level, with line item averages/trend analysis (using Lotus). Manage quarterly goals process (via Lotus) & submit to VP. Manage annual performance review process for the AVP. Maintain master files for General Contractor’s performance evaluations, prepare annual reviews, & set up conferences. Assist AVP in maintaining the group’s top-line process manual. Prepare Project Summaries for store openings, utilizing the Capital Purchasing System database to compile cost to within Acquisitions for Expenditures & % General Contractor change orders.

LensCrafters Temporary Services (SOS) Assignment: President's Pin Coordinator

Corporate Culture position - President’s Pin Coordinator, entailed reviewing letters for eligibility, inputting into Dataease database, communicate with GM’s, prepare customer letters, package awards, and monitor & requisition stock. Prepare quarterly reports for all VP’s, GVP’s, RVP’s, & RDO’s. Focal Point & Eyewitness Newsletter submittals. Interface with Records/HR.

General Electric Aircraft Engines Oct 1979 - Dec 1992

GE Assignment: Engineering Assistant

Assisted engineers with the development of heat transfer analysis computer models of HPT rotor/stator components. Prepared input data utilizing programs on Honeywell, Vax, Cray, IBM & HP Workstation. Coordinated with Drafting access to IGES files used for “meshing” to produce nodes & elements. Used spatial ability to visualize 3D model while creating x-y-z coordinates. Prepared graphical displays of analysis results & engine test data utilizing THTD, Siesta, Patran, Genplot, HTCP, Supercalc/Lotus. Provided fluid systems support by performing rotor thrust analysis, generated flow models using YFT & plotting results. Assisted with DRB documentation by keeping detailed records of computer model being built. Acted as Novell LAN/CC:Mail administrator by setting up users, Monitor file server, assign privileges, create user groups, load software, & provide training to assigned section. Provided technical support to Reliability Engineering through assistance in acquisition, storage, & use of data. Involved interfacing with external vendor on data input into Lotus to produce FMECA reports, uploading/downloading of Lotus files to IBM mainframe, & running SAS to generate report. Monitored vendor work packages, assigned priority, defined formats, evaluated quality & timeliness. Provided software maintenance & documentation of engineering reports.

GE Assignment: Administrative Assistant

Screened phone calls, scheduled meetings, arranged foreign & domestic travel plans and prepared travel reports/expenditures, took shorthand, typed technical memorandums, work authorizations, certification reports, test project sheets, cost reduction forms, etc. Requisitioned supplies, maintained personnel folders & prepared presentations/view graphs. Created tracking systems for work requests, maintained drawing/data files, hardware lists, contractual items. Made arrangements for conferences.

EDUCATION

Cincinnati State Technical College: Associate of Applied Business. Graduated Cum Laude (3.7 GPA)

Loveland High School: Business Curriculum. GPA 3.68. Rank in Class: 7/224.

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