Project Manager Sales

Frederick Hofstetter

Information Security Officer Business Analyst Clinical Data Standards Architect

Township of Randolph, NJ

acefmb@r.postjobfree.com - +1-973-***-****

Life is indeed a trip; are you prepared for the voyage? Every day, we make decisions and take actions on

unexpected events. Whether these events yield a postive outcome (opportunity) or represent a threat, we

respond to risk. Identifying the right tools, processes and people for the journey is key to success. Do you

know your risks, and are you prepared to deal with them when they arise?

Fred has extensive experience in the deployment of systems and services that meet the integrity, availability

and confidentiality goals of customers’ valued information assets, having successfully managed global projects

from inception through solution delivery. He has developed and managed high-performing cross-functional

teams to meet key objectives. Other skills utilized as Clinical Data Standards Architect include a robust

knowledge of the clinical development lifecycle, specifically in data collection (EDC, Oracle Clinical) and

submission (SAS, SDTM) activities. As a IT Business Analyst with mastery of data management as an

information asset, as well as experience in vendor and contract management, he has conducted business from

both vendor and client perspectives. As an Information Security Officer, he has refined service, asset, change

and incident management processes, and is a subject matter expert on identity and access management

processes.

WORK EXPERIENCE

Clinical Data Standards Architect

Novartis Pharmaceuticals Corporation - East Hanover, NJ - 2010 to Present

Architect data models for efficacy data domains for capture, reporting and submission within the ADVANCE

topology using OC/RDC and CDISC SDTM..

Analyze processes, documentation and methodologies to identify opportunities for process improvements,

development of KPIs and associated metrics, and expand acceptance of the developing standards.

Senior Production Support Specialist Information Security Officer

Novartis Pharmaceuticals Corporation - East Hanover, NJ - December 2001 to June 2010

Departmental Information Security Officer responsible for risk-based analysis of business information assets,

integration of Information Technology security best practices into EDC infrastructure, project ISEC compliance

and staff awareness training.

Managed multiple projects related to the upgrade of various Development platforms and the related data

migrations to maximize data integrity and availability.

Subject Matter Expert on global change, incident and identity management processes defined between

Novartis and top-tier information services provider.

Developed current EDC network topology roadmap and defined service levels and key performance indicators

to support one of the industry's best-in-class EDC environments.

Provided consultation regarding regulatory and internal guidelines for information systems architecture,

especially related to GxP, SafeHarbor and 21 CFR Part 11.

Business Analyst/Solution Architect for Global Document Indexation system implementation.

Direct global support organizations to ensure a customer-centric approach to meeting Development's

information technology needs and expectations.

Define high-level technical infrastructure as consultant to ADVANCE project team to integrate Oracle Clinical

and LSH across Novartis Global Development enterprise.

Architect of multiple operational toolsets for management of clinical trials using Novartis EDC to meet or exceed

service-level and performanc3e targets.

Senior Global Project Manager, MIPS Special Projects

Novartis Horsham Research Centre - Horsham, PA - April 2000 to November 2001

Project Manager of PANDORA, a $16M project for the migration of legacy database and reporting migration

systems. Defined the migration factory process and workstreams for globally distributed project team.

Engaged in international assignment for approximately one year in United Kingdom commencing July 2000,

to enhance cross-location interaction and support.

Global Head, MDSP Reporting Support

Novartis Pharmaceuticals Corporation - Summit, NJ - December 1998 to April 2000

Business manager for the implementation and operations of the Global Programming and Statistical

environment (GPS). Defined operational and support models, as well as governed definition of cross-functional

working practices.

Lead development of standard programs and working practices for the development of clinical listings and

tables deliverables that meet FDA and ICH ERF guidelines.

Consultant, Ortho-McNeil Pharmaceuticals

Kelly Technical Services - Raritan, NJ - April 1998 to December 1998

Analyze and report compensation for prescription sales using data derived from Sales Force Automation, IMS

America-supplied and internal databases.

Forecast future sales and market information for various divisional sales forces.

Develop standard reporting tools, with distribution models to target sales of key products.

Lead Project Consultant, Centocor

RCG Information Technologies - Conshohocken, PA - April 1997 to March 1998

Develop generic methodology at Centocor for converting SAS-generated listing files to Adobe .PDF files for

use in BLA and CALA submissions to the FDA.

Evaluate and project computing needs for Centocor's biomedical operations, including effort to evaluate and

recommend replacement for ClinTrial v3.

IVRS Consultant

Premier Research Worldwide - Philadelphia, PA - January 1997 to April 1997

Created rapid application development environment for Interactive Voice Response Systems using object-

oriented programming tool sets, and operationalize use.

Lead Project Consultant

IBAH Biopharm - Blue Bell, PA - February 1996 to March 1997

As part of an NDA submission for a broad-spectrum anti-infective agent, use SAS to develop data delivery

system and generate all the tables and listings for the ISE.

Work with client teams to increase programming efficiency, recommend methodologies to enhance application

development and documentation standards at all client sites.

Recruit and supervise on-site consulting staff for projects at all client sites.

Manager, Information Technology

Nelson and Associates - Philadelphia, PA - March 1995 to January 1996

Designed and developed facilities management software for commercial real estate, primarily for national

financial and insurance institutions with over 20 million square feet of real assets.

Associate Director, Information Systems Development

Research Data Worldwide - Philadelphia, PA - 1992 to 1995

Lead the design and development of global, enterprise-wide information infrastructure including management

of global capital and operational budgets and staff for IT services.

Designed and deployed laboratory information management system for support of clinical trials, from Phase

I through CANDA submission.

Manager, System Services

Cardio Data Systems - Haddonfield, NJ - May 1987 to May 1992

Architect of international telecommunication topology for all locations in UK and US.

Developed systems for analysis and reporting Holter, ABPM, and Lab values for clinical trials, and delivered

that data to biopharmaceutical clients worldwide. Co-developer of the SigmaScan ECG analysis platform, the

forerunner of eRT's current ECG analysis platform.

EDUCATION

Associate's in Project Management

ESI/George Washington University - St. Louis, MO

1999 to 2004

B.S. in Computer Science

Arcadia University - Glenside, PA

1982 to 1987

SKILLS

Information Security, 21 CFR Part 11, IHC-GCP, SAS, SQL, Oracle, VPN, IVRS, Vendor Management, CDISC,

SDTM, Oracle Clinical, Solaris, Unix, Java, Clintrial IV, EDC

LINKS

http://www.linkedin.com/in/fredhofstetter

GROUPS

Adult Leader, Boy Scouts of America

2004 to Present

I have served as the Cubmaster for Pack 53, and moved onto Assistant Scoutmaster, Scoutmaster and now

Troop Committee Chair of Troop 53, Black River District of the Patriots Path Council.

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