Richard J Maloney
Project Manager, Business Analyst, CSV, SEND Readiness, Lifecycle and Data Management
- Role
- Senior Director at Daiichi Sankyo US
- Location
- Scotch Plains, NJ, US
- LinkedIn followers
- 500 followers
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
Experience
Senior Director
Sep 2013 — Present · 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
Long Island University
Master's degree, Computer Science
1998 — 2000
Liverpool John Moores University
Bachelor's degree, Applied Chemistry
George Washington University
Master's Certificate in IT Project Management
NUI Galway
Bachelor of Science (BSc), Science
1989 — 1992
Skills
- Customer Support
- Project Management
- Biotechnology
- Business Analysis
- Lims
- Tmf
- Edc
- Bioinformatics
- Clinical Trials
- Qms
- Data Integration
- 21 Cfr Part 11
- Lifesciences
- Data Management
- Data Integrity
- Oncology
- Life Sciences
- Informatics
- Change Management
- R&D
- Compliance
- Validation
- Cdisc
- Process Optimization
- Clinical Development
- CRO
- Gcp
- Pharmaceutical Industry
- Sop
- Change Control
- Gmp
- Application Lifecycle Management
- Fda
- Drug Safety
- Computer System Validation
- Pmp
- Ectd
- Gxp
- Glp
- Drug Discovery
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