Vijay Britto Email & Phone Number

• Commanded superior leadership and technical management success, positively impacting business performance, by delivering innovative technical and business process solutions such as eClinical and AstraZeneca-MedImmune.
• Supervised/coordinated activities of 15+ team members across the business & IT organization, with expert oversight and guidance, for successful completion of projects.
• Elevated business and technical performance by managing end-to-end technical delivery on the eClinical program, a 3-year initiative budgeted at ~ $10 MM and potential ROI of ~ $1 MM, designed to improve clinical trial.
• Managed the implementation of IMPACT-POLARIS CTMS for improved site selection/initiation/ monitoring, patient recruitment and management/global tracking of clinical studies.
• Expanded organizational capabilities establishing enterprise integration framework based on Oracle middleware to enable information sharing and centralized management, aligned with service based architecture.
• Spearheaded critical implementations creating operational efficiency, by integrating CTMS, EDC, IVRS and PMD systems; enabled real-time data availability, eliminated manual entry and improved data quality.

• Contributed to leadership excellence on organization-wide deployment of key process areas of SEI Capability Maturity Model Level 3 for CTIS’ Process Improvement Initiative.
• Bested industry average of ~ 12-18 months achieving CMMI Level 2 in 8 months and Level 3 in a total of only 10 months. Served on CMMI L2/L3 appraisal team.
• Critical role as leader of Project Management Group. Developed/standardized improved project management processes based on CMMI, PMBOK and RUP best practices.
• Utilized advanced knowledge of clinical research domain & health informatics data standards to establish standards knowledge-base for compliance with 21 CFR Part 11, CDISC ODM/SDTM, Sec 508, E2B.

• Managed the delivery of mission critical enterprise-level systems for National Cancer Institute (NCI/NIH).
• Led the CDUS-AdEERS Reconciliation project to monitor and institutionalize data harmonization between NCI-CTEP’s SAE and routine adverse event systems across 1000+ studies.
• Managed integration of NCI CTCAE v3.0, including implementation of MedDRA v5.0 within CTEP information systems enabling standardized abstraction, analysis and reporting of clinical data.
• Successfully handled a multi-project environment with 5 sub-projects, and 8 live applications, involving 25+ personnel and 100+ external user base and spanning 8 months, with minimal disruption and zero-downtime.

• Managed the development of AdEERS, a de-facto web-based safety reporting solution for NCI-sponsored trials under CTEP; comprehensive site to sponsor/FDA reporting & workflow capabilities reduced the SAE processing time.
• Led requirements gathering, design and analysis for IND tracking system.
• Involved in all aspects of software development accross numerous projects including knowledge acquisition, design, implementation, process/data modeling & data modeling.

Served as a software developer on numerous projects including Imation Photographic Research and Development Support System (IMPRESS) for Imation (Italy) & Environmental Relevant Substance (ERS) for 3M (Switzerland).

B.E., Telecommunications

Education record