MICHAEL KESELMAN

** **** ******** *****, *******, Pa 18966

c: 215-***-****

aday9y@r.postjobfree.com

SUMMARY

Management professional with over 20 years in Information Systems with over 15 years experience in Pharmaceutical Industry Management field with very solid technical experience and strong communication, organizational, interpersonal and leadership skills. I have solid experience in Pre-Clinical, Clinical, Safety, Regulatory IT and relevant business areas.

EDUCATION

UNIVERSITY OF CINCINNATI, Cincinnati, OH

Bachelor Degree in Math and Computer Science

PROFESSIONAL EXPERIENCE

Assurant, Wayne, Pa 11/15 – Present

Manager, Software Implementation and Product Management

In my current role as Manager, Software Implementation and Product Management I am directly responsible for the health and growth of my team that are members by Agile Scrum Team assignment as well as discipline. I am accountable for training plans, reviews, one on ones and other HR related practices. As a manager I am daily engaged with my scrum teams and identifying ways to continuously improve their ability to deliver software products for our external clients. In addition to that, I am fully engaged with our business stakeholders addressing our external and internal deliverables. The emphasis is placed on communication with our business clients and account execs influencing outcomes and quality of the delivered product. My responsibility is to leads across teams making sure that they are aligned and commonly work together to drive organizational outcomes and changes to support growth and efficiencies of my company.

Managing Business Analysts, Software Developers, QA testers and implementation leads to deliver quality systems for our clients in Agile environment.

Standardizing best practices

SaaS implementation

Motivating, coaching, mentoring, providing direction for the entire team

Communicating with product owners, scrum masters on the daily basis

Workplace Renovation projects in IT

Working with Architects, Developers, Quality engineers and production support ensuring timely and smooth deployment, continual operation and delivery of quality software product

Responsible for provisioning of support for new applications, transition of services to internal and external service providers, and issue management and resolution

Bristol-Myers Squibb, Princeton, NJ 08/11 – 11/15

Manager, Research Information Services

As a Manager I am accountable for production support and lifecycle management for specific

applications used by the BMS Research organization. This includes break/fix support, required

modifications and discretionary enhancements to support the application lifecycle.

Management of demand for application defects, required modifications and enhancement requests.

Planning and prioritization of application releases

Support for generation of system requirements

Coordination of User Acceptance Testing

SaaS Implementation, (development, testing and production release)

Oversight of 3rd party service providers, both onshore and offshore

Some tier 2 and tier 3 technical support (triage, break/fix, solution design, delegation of implementation)

Responsible for provisioning of support for new applications, transition of services to internal and external service providers, and issue management and resolution

Primary accountability for the Discovery Medicines and Clinical Pharmacology (DMCP) organization

Accountable for support services and demand management for all centrally-supported applications owned by that business area.

Harte-Hanks, Langhorne, Pa 12/2010 – 8/2011

Manager, Customer solutions and CRM

Managing QA testing, schedule, QA test plans, and test cases.

Managing Projects full SDLC cycle

Ensure contracts are signed by client

Managing compliance and client audits

Responsible for managing the project scope and delivery of project

Responsible for creating and maintaining the Project Plan

Responsible for managing the project from delivery schedule and budget perspective

Responsible for communication to client related to the database build status and risk management

Prepare Change Requests with build team during the implementation.

Coordinate FTP and VPN set-up between Harte-Hanks and Customer.

Collaboration and communication of all DB issues, risk etc with Account Services

Coordination of On-Boarding Team resources

Set up time tracking and budgeting

Managing DB On-boarding with the client

SIC Consulting, TD Bank, Mt. Laurel, NJ 5/2010 – 12/2010

Sr. Manager (CONTRACT)

Managing all testing phases (SIT, BAT, Production and Performance testing)

Automation solutions, QTP, managing HP QC, SharePoint and SRS documentation and defects and issues, system integration, credit and debit cards applications

Coordinating work of Development, DB and Systems/Infrastructure groups during the build implementation and testing cycles.

Establish and maintain traceability of test cases to requirements.

Managing the test protocols, test cases, test scripts, and test summaries.

Perform pre and post test script execution reviews.

Work closely with the Development Project Manager to plan for upcoming development project testing needs.

Work directly with subcontract partners to fulfill project test needs.

Developing estimates for upcoming core product and custom development testing efforts to be used for internal planning and customer proposals.

Administering Product Support to coordinate the recreation of customer reported issues.

Managing and leading local and offshore team. Coaching, and mentoring testing staff.

YOH, Norristown, PA 4/2009-5/2010

PJM – Project management / Environments coordination/ QA/ Release management consultant (CONTRACT)

Serve as a primary contact for the IT needs of the business units and establishing a positive, service-oriented relationship to ensure timely and accurate delivery of IT services.

Development support for Smart Grid & Power Distribution SOA Integration

Management of teams and department management in developing work plans, including scope, milestones, schedule, resources, and deliverables

Managing production migration and production readiness planning

ITIL Leadership: Vendor Management, Service Strategy, Design, Transition, Operation, and Continuous Improvement

HP QC, QTP

SaaS

Prioritizing testing releases for QA/Integration Team

Systems Validation, testing and defects management

Coordinating Change Management and Release Schedules

Developing status reports regarding workgroup or project team status

Logging, tracking and managing software issues and defects detected during testing

Managing project team of testers and software developers

Managing updated versions of Hardware and Software Applications to assist multiple project teams (QA/Integration & Configuration Management)

Research Pharmaceutical Services, Inc. Fort Washington, PA 8/2008-3/2009

Manager, Validation, QC and Testing (CONTRACT)

Leading test execution, providing timely reports of the test results from the test data, resolve issues found during SQA testing.

Developing and maintaining supporting documentation

Vendor Management

In charge of planning, designing and executing of software tests

Logging, tracking and managing software issues and defects detected during testing

Managing project team of testers and software developers

Following Good Automated Manufacturing Practice (GAMP)

Managing the development of the software testing process including:

Gathering test requirements;

Developing test plans, test cases, test reports and test metrics;

Software design specifications in SAS, Oracle Clinical, and Trackware;

Providing technical response for product requirements in terms of traceability to requirements;

Ensuring the software remains compliant with Regulatory Body requirements, specifically FDA 21 CFR, Part 11

PHARMANET, Princeton, NJ 8/2006-7/2008

Manager, Data Management, Validation, QC and Testing

Directed the day to day activities of the IT Data Management support team, IT Audits, QA and QC functions, administrative management of the Testing/Validation team including recruiting, performance appraisal, coaching, and professional development.

Supervised and trained Data Management staff, established methodologies, standards, and procedures for requirements analysis, test plan preparation, test procedure development and execution, documentation of results, and reporting.

Managed the release of software including preparation of release notes, and produced software quality metrics and communicate same to development team.

Interfaced with Pharmanet IT staff to ensure proper maintenance of Clinical Data Management Systems (CDMSs), including requests for new instances and database links.

Ensured the duties of a CDMS support specialist are performed to effect minimal downtime and quick problem resolution.

Acted as CDMS Database Administrator by providing new user accounts, user groups, updating user groups and system parameters.

Ensured that all project-related programming tasks are completed in accordance with PharmaNet standard practices from commencement to closure of a project, within SOX compliant environment. Ensuring the software remains compliant with FDA 21 CFR, Part 11 and SEC regulations.

HP QC, Test Director, Rational Rose, QTP

Supported the implementation of the ITIL framework to the DM team for both applications and infrastructure

Tracked milestones and issued reports of database release and edit checks.

Participated in the strategic planning for Data Management related system development projects conducted by IT or external consultants.

Assisted in the creation and documentation of new or revised departmental procedures, designed and implemented project-related reports.

Represented Data Management at Business Development or other sponsor related meetings and at professional meetings.

Coordinated the validation of a CDMS or related supporting software, wrote materials and/or perform technical training for Data Management staff.

LOCKHEED MARTIN, Moorestown, NJ 3/2001-8/2006

Manager, System Engineering

Managed computer system administration functions in support of the Technical Operations Computer Center including application support, infrastructure set up and support delivery

Led the installation, integration, and management of computing systems and software applications used to support Technical Operations engineering development activities.

Managed the installation and integration of various types of client and server computing equipment into the classified and unclassified environments.

Oversaw engineering environments across Technical Operations, including the evaluation, selection, and procurement of new engineering software tools.

Interfaced with engineering managers and technical staff to assure that computing environments met business and program needs.

Defined and implemented performance metrics to measure and improve overall performance of software tools and engineering environments used across Technical Operations organization.

Maintained technical liaison with Software Engineering, Program Management, Vendor management, System Engineering and customer representatives.

Managed technical planning, system integration, verification and validation, cost and risk, and supportability and effectiveness analyses for total systems.

Coordinated employee recruitment, selection and training, performance assessment, work assignments, salary, and recognition/disciplinary actions.

Ensured analyses performed at all levels of system product including concept, design, fabrication, test, installation, operation, maintenance and disposal.

Directed the logical and systematic conversion of customer or product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.

Managed the functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Headed skilled, experienced, and senior level exempt professional staff units.

Provided critical assessment of operational performance, workflow analyses and processes based on extensive experience.

Interfaced with and coordinated support and workflow across programs and operational organizations to facilitate mission success.

FIRST CONSULTING GROUP, Wayne, PA 10/1999-3/2001

Contracted to MERCK, Blue Bell, PA

Senior Computer Consultant (Master III), 12/2000-3/2001

Managed a group of consultants developing/implementing Fraser Williams IMPACT application Interface using API and PL*SQL.

Responsibilities included resources management, hands-on management of day-to-day activities, and implementation of management directives to software development and support, testing and full project implementation.

Contracted to SMITHKLINE BEECHAM, Collegeville, PA,

Senior Computer Consultant (Master III), 1/2000-7/2000

Provided project management, clinical analysis, and systems support for the implementation of next generation Clinical 4.2 software for the Clinical system.

Created system documentation, executed systems testing and validation that duplicated the production environment using real data on system components.

Provided daily user support (problems/errors resolution) to the Clinical Data Management group.

Performed Clintrial, system administration including systems accounts maintenance, database maintenance, database import/export, and training environment set up, supported the Clintrial 3.3 production system.

Contracted to AMGEN, INC., Thousand Oaks, CA

Senior Computer Consultant (Master III), 10/1999-1/2000

Responsible for the analysis and documentation of user requirements for ordering reagents and laboratory materials in support of drug development processes.

Defined the project scope, users and groups, usage scenarios, system architecture, and requirements for the Amgen Chemical Inventory Management (CIM) system, which managed reagent ordering and tracking.

Built process flow diagrams and used case scenarios to support the analysis and presentation of requirements.

Analyzed current application architecture (current applications, packages, and tools) and determined how the new ordering functions could be integrated into the new business process and technical environment.

ICT GROUP, Langhorne, PA 1/1999-10/1999

Director, Systems and Technology

Oversaw the design, development and implementation activities of numerous projects and systems for Telemarketing clients.

Project management for TeleSolutions and Medical Marketing groups within Systems & Technology division.

Responsible for project distribution, assignments and tracking for the department, as well as personnel development, reviews and training.

Performed technical presentations on various technologies for client.

SANOFI RESEARCH, Malvern, PA 3/1996-1/1999

Project Manager/IS Specialist

Provided project management and Oracle database administration to the Clinical area as Systems/Application Manager for Clintrial, Clinical Study Status System (CSSS) and Discrepancy Resolution System (DRS), Document Management System for Electronic submission.

Coordinated the support and upgrades of Clinical Information environment with business partners and users world-wide.

Contributed to the database analysis, design, development, implementation and support overall Clinical Information Management infrastructure and strategy including integration with other environments to achieve the goals of timely capture of high quality data, deployment of internal review tools and readiness of data for international submission.

Member of Globalization Project teams with overseas IS and CDM Groups.

Responsible for system implementation including Oracle database support, re-engineering, client training, application support and quality control of data

CORNING BESSELAAR, Princeton, NJ 8/1995-3/1996

Senior Analyst, Project Manager

Provided primary analysis, design and development support to the Clinical data analysis and the SAS application development environment.

Provided application programming support for all areas of clinical development using SAS in UNIX environment.

WYETH-AYERST (Pfizer), Radnor, PA 8/1988-8/1995

Programmer Analyst/ Project Manager

Worked as a Project Manager for various Drug projects and applications provided programming support and training for Clinical R&D projects individually and as a part of the team in Oracle and SAS database environments.

Independently analyzed requirements and computer capabilities; designed, developed, validated and documented structured programs and complex systems for clinical research applications in DEC, IBM Mainframe and PC environments.

Interfaced and closely worked with biostatisticians, data management, clinical writers, medical personnel, and computer services to support initiatives and worldwide submissions.

Reviewed various programming activities of junior level programmers.

Other positions held include: Computer Consultant, Systems Analyst, and Systems Engineer at companies such as: Cap Gemini Consulting, First National Bank of Cincinnati, and ARMCO Steel.

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