Principal Consultant @ Odyssey Enterprises International
Clinical Data Standards Architect @ Novartis
Lower Moreland High School, Huntingdon Valley, PA
Integrity meeting excellence.
Every day, we make decisions and take actions on unexpected events. Whether these events yield a positive outcome (opportunity) or represent a threat, we respond to risk. Identifying the right tools, processes and people to complete the enterprise's odyssey to success is crucial. Do you know your risks, and are you prepared to deal
Integrity meeting excellence.
Every day, we make decisions and take actions on unexpected events. Whether these events yield a positive outcome (opportunity) or represent a threat, we respond to risk. Identifying the right tools, processes and people to complete the enterprise's odyssey to success is crucial. Do you know your risks, and are you prepared to deal with them when they arise? Fred can be your guide, at the vanguard on your journey.
Fred has extensive experience in the deployment of solutions that meet the information security goals of integrity, availability and confidentiality for customers’ valued information assets, and has successfully managed multimillion dollar global projects from inception through solution delivery. He has developed and managed high-performing cross-functional teams to meet key objectives. Other skills include a robust knowledge of the clinical development lifecycle, specifically in data collection and submission activities, with mastery of data management as an information asset, as well as experience in vendor and contract management, conducting business from both vendor and client perspectives. From an IT perspective, he is a subject matter expert on security, quality, service, asset, change and incident management processes.
Principal Life Sciences Consultant @ From November 2014 to Present (1 year) Randolph, NJPrincipal Consultant @ From March 1996 to Present (19 years 8 months) Randolph, NJClinical Data Standards Architect @ From June 2010 to June 2014 (4 years 1 month) East Hanover, NJInformation Security Officer | Senior Technical Project Manager @ From December 2001 to June 2010 (8 years 7 months) East Hanover, NJGlobal Project Manager, MIPS Special Projects @ From April 2000 to December 2001 (1 year 9 months) Horsham, West Sussex, United KingdomGlobal Head, MDSP Reporting Support @ From December 1998 to April 2000 (1 year 5 months) Summit and East Hanover, NJ; Basel, SwitzerlandSenior Consultant @ From March 1998 to December 1998 (10 months) Raritan, NJLead Project Consultant (RCG Information Techniologies) @ From May 1997 to March 1998 (11 months) Malvern, PAIVRS Consultant (RCG Information Technologies) @ From January 1997 to May 1997 (5 months) Philadelphia, PALead Project Consultant (RCG Information Technologies) @ From January 1996 to January 1997 (1 year 1 month) Blue Bell, PAManager, Information Technology @ From February 1995 to January 1996 (1 year) Philadelphia, PAAssociate Director, IT Development @ From January 1992 to January 1995 (3 years 1 month) Greater Philadelphia AreaManager, Systems Services @ From May 1987 to December 1991 (4 years 8 months) Haddonfield, NJ & Peterborough, Cambridgeshire, UK
Bachelor of Science @ Arcadia University From 1982 to 1987 Lower Moreland High School, Huntingdon Valley, PA From 1978 to 1982 Fred Hofstetter is skilled in: Pharmaceutical Industry, Cross-functional Team..., 21 CFR Part 11, Integration, Clinical Trials, Validation, Business Analysis, SAS, Databases, IT Management, Public Speaking, Information Security, Effective Communications, Creative Thinking, Analytic Problem Solving, Instructor-led Training, IT Service Management, Computer System..., ICE methodology, SDLC, Change Management, Vendor Management, Risk Assessment, Data Management, Oracle Clinical, Management, ITIL, Clinical Data Management, CTMS, Software Development, Business Intelligence, SAS programming, CDISC, SDTM, Regulatory Submissions, Unix Shell Scripting, LIMS, EDC, System Architecture, GCP, CRO, Information Technology, Unix Operating Systems, SharePoint, Cardiovascular, Clinical Laboratory..., Clinical Trial Analysis, Diabetes Management, Information Governance, Unix
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