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25 years of experience in application and database development, business relationship building, project management, data migration and analysis. Pharmaceutical expertise in pharmacovigilance and clinical systems and processes.
Revolutionary Technology Inc
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Client ConsultantRevolutionary Technology Inc Jan 2023 - Present
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RelocationCareer Break Jun 2022 - Dec 2022Including packing, selling and settling in to be near the granddaughters and taking time to be with them, too! Now back to work....
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Senior Principal At Prudentia GroupPrudentia Group, Llc Jan 2020 - Jun 2022Jersey City, New Jersey, UsProviding pharmacovigilance subject matter expertise and leading end-to-end drug safety engagements. This includes up-front strategy and planning, through systems implementation and testing. -
Senior R&D ConsultantRevolutionary Technology Inc Apr 2016 - Jan 2020R&D Data Integrity Assessment• Managing the activities for the assessment of GxP gaps at global lab sites• Compiling and harmonizing Remediation plans• Forecasting budget for current remediations and future site assessments/remediationsHealth Registration Management System Selection and Implementation• Oversaw the decision and response for evaluation of Veeva Vault RIM Suite verses Liquent Insight • Forecasted $4M budget and gained approvals for project resources, vendor and hardware upgrade costs• Planned business (SOP updates, Training, Communications) and IT (suppliers, internal service groups, development and testing) activitiesWorkDay implementation to replace PeopleSoft• Collaborated with reporting data warehouse team, operations data owners and downstream application stakeholders to communicate data conversion rules, track progress and prepare for UAT of affected systemsMedical Affairs CRM Tool• Stood up a Salesforce.com-based solution to be used by Field Medical personnel to record and catalog contacts with external HCP colleagues and – if applicable – any adverse events noted PV Program Tracking System• PM and BA for global inventory and workflow system developed on a validated OpenText Metastorm platform for tracking identified programs – such as focus groups, market research surveys, patient support programs and social media – that may produce AEs• Authored, edited, routed and administrated approval of SDLC validation documents via documentation management system
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Engagement LeaderQuintiles Technology Solutions Sep 2013 - Apr 2016Durham, North Carolina, UsClient Liaison• Developed client IT Roadmap, creating opportunities for joint application and process initiatives• Created integrated Help Desk workflow process with client to improve process efficiencies and promote account growth• Eliminated complexity by driving the successful implementation of Single Sign On (SSO) for several clients resulting in prospects for additional in-house application licensing contracts• Oversaw creation of Excel outputs and statistical visualizations for client Country Operations and Product Development group as part of onsite engagement to increase consulting revenuePharmacovigilance SME• Averted compliance errors originating in data requirements for automated transfer of AEs from multiple Quintiles EDC systems (InForm, Medidata Rave and Outcome) to client’s Argus PV system• Audited European client’s compliance risk related to downstream systems used to notify global Investigators and Ethics Committees of SUSARS extracted from ARISg• Assembled team to create US client’s SOPs for governance of AEs collected in Quintiles Japan clinical study• Reviewed and edited communications and governance protocols incorporated into SMP • Developed processes and system workflow for safety reporting across Japan, China and the US Business Development• Formed and led team to craft $20M+ response to global pharma company PV System RFP• Created $2M proposal to implement CTMS solution at a national medical center for the purpose of attracting and tracking a greater number of clinical trials Project Manager• Implemented PRIMO application for email intake of Argus SAEs by engaging client, vendor and global Quintiles team• Created plan and pricing model for analytics needed to integrate outcomes from multiple subject screening test results for client’s strategic portfolio study • Forecasted costs and timelines for Medical Data Review visualizations in Spotfire • Gathered requirements for 3rd party vendor access to client’s CTMS system -
Senior Director3C Company Apr 2012 - Sep 2013Cranford, Nj, UsBusiness Development• Created client proposals for:- $50K analysis and prototyping to build PRO questionnaires from a secure library of standard questions- $500K data migration of site budget data from Oracle Siebel to IQVIA SaaS solution• Presented capabilities for Oncology IT PMO resource staffing at a major pharmaceutical companyAdministration• Responsible for employee professional development, employee reviews, recruiting, hiring and internal budget forecastingProject Manager• Successfully migrated data from client legacy CTMS to Oracle Siebel• Implemented industry marketed iPad ePRO solution to collect and aggregate PRO dataMarketing• Created and hosted industry webinars: - "Data Migration: Best Practices and Methodologies" - “Automate your Clinical SOPs to improve efficiency with SharePoint Workflow Solutions”• Sponsored and attended industry conferences -
Executive Director/PartnerThe Norstar Technology Group, Inc. 2000 - 2012Business Development• Recruited and placed multiple consultants on assignments resulting in annual revenue of up to $4M• Created vendor contracts and service level agreements (SLA)• Responded to RFPs and client professional services requirementsClient Liaison• Served as acting manager of GPV Operations department for large pharmaceutical client - Mentored and supervised a team of 8 to liaise with business and IT to design, develop and test new and updated Oracle AERS reports - Scheduled cross-departmental activities and data checkpoints for completion of periodic HA reports - Defined and executed queries for HA reporting analysis, medical inquiries and legal responses - Created medical device reports and integrated all other HA reports/data from legacy ClinTrace system - Worked with business to develop SOPs related to PV data analysis and HA reporting - Ensured adherence to 21 CFR Part 11 and testified before EMEA auditors to confirm compliance• Managed team of over 30 IT and business associates for clean-up of custom PV application data• Conducted interviews with pharmaceutical company executives and department heads to gather requirements for Clinical Data WarehouseProgram Manager• Japan Workstream Lead for Oracle Argus J Safety Database implementation Project Manager• Developed pre-site management planning capability for existing CTMS• Integrated COTS grant management system with custom CTMS• Remediated and tested impact of Euro Conversion on grant management system transactions• Wrote Stress Testing Standards for pharmaceutical company’s R&D IT applications• Initiated automated testing of custom CTMS updates and partnered with testing vendor to define best automated testing practices for client R&D IT• Negotiated with central lab vendors to define format of input files used to create visits in company CTMS
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Managing ConsultantAutomated Concepts Inc. 1996 - 2000Client Liaison• Managed consultants onsite at Sony Electronics Corp• Trained sales staff at various Sony US sites on MS Outlook and custom workflow add-on Project Manager• Stood up PowerBuilder/Sybase application to track Sony shipments after 3 failed attempts by competing consulting firmsDatabase Administrator• Oracle DB designer and administrator for several State of NJ custom application projects • In-house SQL Server DBA Developer• Developed Unix Korn Shell script to monitor Sony mainframe jobs with integrated off-hours notification• Implemented a help desk voice response system for user-initiated password resets at Sony• Wrote Oracle PL/SQL packages to generate SGML file for publishing of McGraw-Hill World Aviation Directory • Creatively used Crystal Reports to generate custom surveys/questionnaires sent to World Aviation Directory advertisersExemplary Consultant Award
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ManagerAt&T 1992 - 1996Client Analyst• Provided LAN Administration, UNIX administration, and PC technical support to the Sales Account Assignment and Results Tracking (SAART) application development group.• Imaged and distributed PC's and laptops to SAART group using Windows for Workgroups for Microsoft LAN Manager connectivity, a Wollongong Pathway Access v3.0 TCP/IP stack, AT&T Easy Link Access Plus version 2.7 for e-mail, and various software packages such as Microsoft Office v4.3, Microsoft Visual C++, and Micro Focus COBOL• Initiated remote access solutions for diverse needs of members of SAART• Monitored and troubleshot daily build of system test area for on-line programmers• Administered several in-house Visual Basic applications used for development and intradepartmental communication• Wrote and maintained Windows installation programs for SAART applications• Release manager for new versions of SAART to a field of over 700 usersSystems Applications Programmer/Analyst• Designed, wrote, tested, and maintained programs for the Service Rate Database(SRDB) on a UNIX platform using embedded SQL in C programs accessing an INGRES database• Ported applications from Amdahl located in Denver to local NCR-3550• Converted application programs from INGRES 5.0 to INGRES 6.4• Initiated use of Dynamic SQL as a practical tool in future application programs
Tim Kenny Skills
Tim Kenny Education Details
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The City University Of New YorkCollege Of Staten Island -
Fordham UniversityCollege Of Business Administration
Frequently Asked Questions about Tim Kenny
What company does Tim Kenny work for?
Tim Kenny works for Revolutionary Technology Inc
What is Tim Kenny's role at the current company?
Tim Kenny's current role is Client Services.
What is Tim Kenny's email address?
Tim Kenny's email address is tk****@****grp.com
What is Tim Kenny's direct phone number?
Tim Kenny's direct phone number is +191389*****
What schools did Tim Kenny attend?
Tim Kenny attended The City University Of New York, Fordham University.
What are some of Tim Kenny's interests?
Tim Kenny has interest in Kayaking, Children, Boy Scout Leader, Hiking, Camping.
What skills is Tim Kenny known for?
Tim Kenny has skills like Pharmaceutical Industry, Clinical Development, Pharmacovigilance, Sdlc, Project Management, Clinical Trials, Business Process, Integration, Business Intelligence, Cross Functional Team Leadership, Management, Software Development.
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