Richard J Maloney

Senior Director @Daiichi Sankyo US

Scotch Plains, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2013 — Present

Senior Director @Daiichi Sankyo US

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Basking Ridge, NJ, US

Understand business demands, identify opportunities and deliver informatics solutions to address near and long term needs for business functions in the US, EU, and Japan. Establish and build collaborative relationships with stakeholders, strategic vendors and software providers.

EDUCATION

1998 — 2000

Long Island University

Master's degree, Computer Science

N/A

Liverpool John Moores University

Bachelor's degree, Applied Chemistry

N/A

George Washington University

Master's Certificate in IT Project Management

1989 — 1992

NUI Galway

Bachelor of Science (BSc), Science

SKILLS

Customer SupportProject ManagementBiotechnologyBusiness AnalysisLimsTmfEdcBioinformaticsClinical TrialsQmsData Integration21 Cfr Part 11LifesciencesData ManagementData IntegrityOncologyLife SciencesInformaticsChange ManagementR&DComplianceValidationCdiscProcess OptimizationClinical DevelopmentCROGcpPharmaceutical IndustrySopChange ControlGmpApplication Lifecycle ManagementFdaDrug SafetyComputer System ValidationPmpEctdGxpGlpDrug Discovery

ABOUT RICHARD J MALONEY

Dynamic IT Project Manager-Business Analyst with extensive experience in defining, realizing and supporting informatics solutions for meeting diverse R&D challenges. A team player with a strong understanding of the relationships between business, technology and regulation.Specialties- Manage informatics projects from inception through implementation- Thorough understanding of GxP and 21 CFR Part 11 regulations- Computer System Validation (CSV) expertise - Experience with for multiple technologies within the R&D application portfolio including TotalChrom, Watson LIMS, PathData, Rave EDC and TrackWise- Problem analysis, risk analysis and business requirements definition- Data governance- Comprehensive understanding of CDISC’s SDTM, ADaM and SEND standards- Science/IT background providing a strong understanding of scientists’ informatics needs

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