VIKAS SINGH
**** ******* **** **** *******, MA **451 Phone: 203-***-**** Email: ************@*****.***
PROJECT MANAGER AND BUSINESS SYSTEMS ANALYST
Project Manager and Business Analyst with exceptional planning, organizational and leadership skills demonstrated through project management and business analysis. Expert in gathering, analyzing and defining business and functional requirements; creating global metrics, trend charts and other decision-making tools; leading process-mapping initiatives; designing/re-engineering processes, workflows and technology solutions for Information Technology systems. Proven ability to lead seamless implementations and deliver next-generation technical solutions improving revenues, margins and workplace productivity.
Expertise Highlights
Project Management
Strategic Technology Planning
Data/Business/Systems Analysis
Data Flow & Process Mapping
SQL Queries & Data Modeling
Electronic Data Capture (EDC) Systems
GAMP, GCP, ASTM E2500, and ISO 13485
Quality Assurance
Knowledge of Salesforce.com
Knowledge of Business Objects Lean, Agile, RUP and Scrum Development Methodology
Major Software/Systems Implementations
Testing/Scripting/Documentation
Technical Writing (Manuals/System Specs)
Corrective and Preventive Actions & Measures
Risk Analysis and Mitigation Planning
21 CFR - Part 11, Part 820 and Part 210/211
FDA, HIPAA, CMMI, and Six Sigma (6σ)
Clinical Systems – Rave, Argus
Professional Experience
BOSTON SCIENTIFIC CORPORATION Feb 2008 to Present
Project Manager/Business Systems Analyst/Validation Specialist Sept 2010 to Present
Business Systems Analyst/Validation Analyst Feb 2008 to Aug 2010
Transitioned into Project Manager in Clinical Department to provide IT leadership for database development for Clinical Trials. Managed large-scale clinical trials database development, process improvements and monitoring of cross-functional teams. Help set long-range technical direction and capacity plans
Worked as a Consultant from Feb 2008 to Oct 2008
Key Results:
• Project Manager on Clinical Trials Database Release (Average Budget of $3M) to be used to store data for ongoing Clinical Trials
• Project Manager/Member for validation of SharePoint 2007 (Budget of $5K) for inter-company use
• Project Manager on Compliance Report Streamlining initiative which was to be used by the management
• Project Manager on Innovation Initiative in the IS Organization to document and implement the innovative ideas that’ll increase productivity and employee attrition
• Team Lead on the IS Rotational Program which was geared towards recent graduated students leading the Program Brochures team for the program
• Team Lead on the Emerging Market Initiative (EMI) Initiative focusing on Cultural Differences and Knowledge Transfer challenges for program’s success
• Analyzed all aspects of Report Validation and Payment Compensation process to ensure workgroup efficiency (from 15 days to 3 days) and profitability
• Gathered and assessed needs from internal business units; created custom solutions to resolve issues and developed functional specifications and design document for Payments group.
• Generated excitement and buy-in to secure commitment to project objectives, and shared a group vision to start the team on a motivated track
• Held post-release review meetings to revisit project strengths and liabilities, and to build out better process for future project releases. Team building and wrap-up continued up to this point.
• Validation Specialist on the Validation of Payment Compensation Process used for processing clinical trial payments to sites and/or subjects
• Validation Specialist on the Validation of Safety Event Notification Reports (SENR) and Non-Safety clinical trial reports for Clinical Studies
• Developed and Updated CRF Folders, Forms, Dictionaries and Edit Checks used for Clinical Database design for Clinical Studies in Medidata Rave
• Team member on the team that introduced PMBOK based SDLC process in the organization
• Subject Matter Expert (SME) on the Roll-Out of Change Control process on Rational ClearQuest platform for global users.
• Software Quality Engineer/Validation Analyst on two extensive intra-company integration projects (more than $50M budget) to integrate different SAP R/3 and PDM Instances
• Software Quality Engineer/Validation Analyst on the project which catered to the delivery of Global Sales Report (Budget of $15M) for the CEO of the company
• Software Quality Engineer/Validation Analyst on SAP FI and SAP BW systems’ change control ensuring adherence to Compliance and Regulations.
• Software Quality Engineer/Validation Analyst on the project which involved release of Hyperion and Cognos based Forecasting, Compliance and Reporting system (Budget of $5M)
• Conducted business analysis, project assessment and feasibility determination of critical systems
• Created Postcards to provide study development status to the stakeholders
• Interacted with auditing bodies during internal Quality Audits for Quality Systems
• Provided feedback and solutions to Quality Audit observations
• Created and Updated Corporate and Site Standard Operating Procedures (SOP) and Work Instructions (WI)
ASPIRE SYSTEM LLC Jan 2007 to Oct 2008
CLIENT- THE HARTFORD LIFE INSURANCE
Business Systems Analyst Oct 2007 to Jan 2008
Project was launching the Life Insurance coverage for Ex-Pats globally with partnering with local Insurance companies.
Key Results:
• Conducted user interviews, gathered requirements, and analyzed the requirements for the new solution.
• Well versed with Sale, Premium and Claim processing of a Insurance Case from Quoting to finalizing, claim review, identifying claims processing problems, their source and providing alternative solutions
• Researched the existing international process and aligned the system in compliance with the HIPAA regulations.
CLIENT- BOSTON SCIENTIFIC CORPORATION
Business Systems Analyst May 2007 to Oct 2007
Project was performing GAP Analysis on the Global Complaints Systems to ensure that the entire system validation was audit ready
Key Results:
• Conducted meetings with the Business and the Functional Owner on risks associated with the system functionality (Risk Engineering), detailed/high level review sessions, team organization to derive and executed action plans to meet required deadlines and standards.
• Ensured compliance requirements (21 CFR Part 11, 21 CFR Part 820 and ISO13485) are met and/or exceeded on designated activities.
• Traced the Test Cases and Design Specifications to SSRs and then to BPRs by using DOORS 7.1.
CLIENT- CIGNA HEALTHCARE
Business Systems Analyst Jan 2007 to Apr 2007
Project was part of a group called as Flights and included updates to the ID Cards and Brochures
Key Results:
• Conducted meetings for risks associated with the projects (Risk Engineering), detailed/high level review sessions, team organization to derive and execute action plans to meet required deadlines.
• Ensured that the system being developed is Six Sigma (6σ) compliant
Other Experience
UNIVERSITY OF BRIDGEPORT, CT Aug 2004 to Aug 2009
Adjunct Faculty Aug 2007 to Aug 2009
Graduate Assistant, Dept. of Electrical Engineering Feb 2008 to Aug 2010
Key Results:
• Introduced and Taught Master’s level courses in Communications and Biomedical engineering field
• Involved in documenting all aspects of computer systems Validation life cycle in accordance with FDA regulations and ensured the system performance was up to the CMMI standard
• Taught Matlab and Pspice software labs and class room courses
EXIDE TECHNOLOGIES
Trainee (part time/concurrent with college studies) Oct 2002 to Oct 2003
Key Results:
• Responsibilities included reviewing the business process and documenting in accordance with Indian Standards Institution (ISI) standards (same as FDA in USA).
BOSTON COMPUTERS
Trainee Software Engineer Apr 2001 to Jun 2001
Key Results:
• Trained and worked on live projects built on C# (β Version) software language.
WINTECH COMPUTERS PVT. LTD.
Trainee Software Engineer Apr 2001 to Jun 2001
Key Results:
• Trained and developed websites using ASP, Java, XML, HTML languages.
Education
UNIVERSITY OF BRIDGEPORT, CT
Master of Science in Electrical Engineering, 2006
PUNE UNIVERSITY, PUNE, INDIA
Bachelor of Engineering in Instrumentation & Control, 2003
Technology Summary
Databases Oracle, MS Access, DB2, SQL Server 2005, SQL Server 2008
System Design & Development Requirement Analysis, Functional Analysis, Data Modeling, Testing,
Documentation and Implementation
Other Skills Testing Methodologies, Technical Writing, System Documentation,
Data Warehousing, Change Control, Web Services, SAP Basis,
Electronic Data Capture Tool(s), SAS, CAPA, Knowledge of Salesforce.com and Business Objects
SDLC Methodologies Rational Unified Process (RUP), Agile, Lean, Scrum and Waterfall
GUI/Tools MS Office including MS Project, MS FrontPage, MS Visio and MS
Access, PDM Windchill, DOORS 7.1, SOAP, Medidata Rave, MS
SharePoint 2007, Argus
Industry Standards HIPAA, 21 CFR Part 11, SOX, CMMI, Six SIGMA (6σ), 21 CFR Part
210/211, 21 CFR Part 820, ISO 13485, GAMP, ASTM E2500
Platforms Windows NT/2000/XP, MSDOS, Linux, Mac
Programming Languages C, C++, Java, HTML, ASP.net, XML, JSP, C#, WSDL, SAP ABAP
Defect Tracking/Change Control Test Director 6.x/7.x/8.x (Quality Center), Rational ClearQuest
Testing Tools WinRunner, LoadRunner, Quick Test Pro (QTP), RQM