An entrepreneurial leader in Information Systems and Software Engineering who sets and implements technology directions with extensive management and hands-on technology experience on Enterprise Architecture, Program and Project Management, Business Analysis, and Strategic decision making to deliver optimum return on investment.

I have 20+ years of extensive experience handling complex, multiple and parallel projects of varying sizes from initiation to execution and disposition spanning geographical boundaries across the world. Strong hands-on experience on a diverse set of technologies along with strong customer focus and negotiation skills makes it possible for me to think outside of the box to present a business solution.

I have been deeply involved for many years in drug development, market research and Clinical Trials of all stages, Regulations, Data Management, GCP, 21 CFR Part-11.

·               Global Leadership experience in IT Products and Portfolio Management with distributed team. Experienced in efficient Corporate Outsourcing Model.

·               Hands-on Enterprise Architect with knowledge and expertise on major technology platforms. Able to move from details to executive level effortlessly to shape the optimal outcome for products and business.

·               Project life-cycle Management and Best Practices on development, Project Management, Budgeting, Planning and Performance Tracking with teams spanning geographical boundaries across US, Europe and Asian countries.

·               Manage cross-functional dependency and critical path for product development.

·               Develop Key Performance Indicators (KPI), critical success factors and asses the outcome of the initiative.

·               Risk Management and Mitigation Planning, Capacity Planning.

·               Health IT, Clinical Trials and Drug Development Process, EDC, EMR and Medical Coding Software. Trained in FDA and MHRA regulations, HIPAA privacy rules, 21 CFR Part 11, GCP.

·               Rich experience on a diverse set of software technologies – proprietary and open source. Focus on security and privacy in a regulated environment.

·               Full SDLC Project and product life-cycle Management. Best Practices on development. Experienced in both Waterfall and Agile development styles, RAD processes.

·               EPLC and CPIC Knowledge and practicing experience.

·               Government IT security policies and procedures.

·               Exceptional Negotiation and Presentation Skills – Deal Maker.

 

National Institutes of HealthFrom 2009

IT Specialist, Applications Manager, and Enterprise Architect

Summary of Roles & Responsibilities

·               Served in three institutes – NIDDK as IT Specialist, NIDA as Applications Manager, and currently at NHLBI as the Enterprise Architect for the whole institute’s IT Center. Certified COR (Contracting Officer’s Representative) – provided procurement assistance and management of IT contracts.

·               My current position at NHLBI is to provide organization wide oversight on Enterprise Architecture. My team's current contract is about $14 million. Within the architect team I manage, we have about 15 projects of varying sizes concerning new technologies, proof of concepts and provide architectural framework to the organization.

·               Besides my own team's projects, I also provide program management service over 5 other projects run by contractors as a solution delivery manager. Following initiatives are some of the example activities in the portfolio:

o                 Provide Enterprise Roadmap from ITAC.

o                 Plan and Implement an Identity Access Management Solution with SailPoint Identity IQ Product.

o                 Plan and implement enterprise storage options.

o                 Provide a roadmap and assist implementation of Enterprise Content Management System.

o                 Provide guidance to Talend Enterprise Application Suite adoption.

o                 Provide assistance to creating many task orders from ITAC.

o                 Provide the bridge between Application Development, SysOps, EA Team, and Security Team.

o                 Provide ongoing stage gate reviews for architectures proposed by various contracted teams, so that they make sense while brought into the Enterprise System.

·               Lead the team supporting and reengineering the NIDA Enterprise Project System. This is the backbone of the NIDA business. It has modules for budgets, grants management and other supporting functions for NIDA’s day-to-day operations. It works as an overlay on top of IMPAC-II data.

·               Organizational leadership implementing standardized and transparent processes to manage the delivery pipeline where competing priorities exist among key stakeholders. Adhere to standard project management and EPLC guidelines as applicable to NIDA.

·               Help the ISSO and the team to adhere to federal security guidelines and requirements such as FISMA and making sure the acquired services meets FedRAMP certification.

·               Collaborate with stakeholders across the organization and manage customer expectations.

·               Promote efficiency on delivery by improved standards and new technology adoptions.

·               Evangelize product delivery improvements for other institutes in NIH.

·               Evaluate COTS products and custom development options to provide the required business solution.

Key Accomplishments

·               Driving key initiatives involving new technologies at NHLBI.

·               Successful management of Applications Support and Development group at NIDA helping to ease customer pain points, lead innovative business solutions in domains of business and science.

·               Actively involved in new and innovative solutions at NIDA with budget, travel, scientific portfolio analysis using a mix of technologies Java and Microsoft platforms.

·               Managed, architected and developed a new delivery platform for NIDDK to deliver applications faster in order of times. The framework helped eliminate common application errors in data transaction while facilitating rapid application delivery.

·               Created a new dynamic and specialized survey delivery framework to web and handheld mobile devices for the scientific community.

·               Developed advanced algorithms for hepatoxicity research following bioinformatics theories at NIDDK. Delivered end-to-end solutions for hepatoxicity research data collection

o        http://livertox.niddk.nih.gov

·               Solution for multiple grants management applications:

o        http://stepup.niddk.nih.gov (Short-Term Research Experience for Underrepresented Persons)

o        http://dsrtp.niddk.nih.gov (Diversity Summer Internship Program)

o        https://forms.niddk.nih.gov/nmri/ (National Minority Health Research Investigators)

Awards

·               2013 Annual NIH Director’s Award from Dr. Francis Collins

·               2011 Annual NIDDK Director’s Award.

Technology Domains Expertise

·               Advanced enterprise architect level skills on Microsoft .Net and SharePoint technologies,

·               Database management and modeling with hands-on abilities,

·               Open source, Java technologies.

Medidata Solutions, NYC2005-2009

Development Director

Summary:

·               Worked with the executive management leading the company's principal software products in the market. Responsible for analyzing the business requirements myself and provide oversight to junior managers and developers.

·               Collaborated with the representatives of global client pharmaceutical companies to elicit desirable product features.

·               Collaborated with external SMEs on product development.

·               Periodic executive reporting on project status, risk and mitigation plans, budgeting and time-lines.

·               Collaborate and guide the product managers on describing product features, market positioning, and pricing.

·               Conduct regular architecture and design reviews for our products and suggest improvements.

·               System Architecture reviews for hosting to make sure that our hosted applications are available up and running 24 x 7 across the globe. Collaborated with IT technicians and managers.

·               Collaborate with the corporate and product strategy team members to keep the projects in line with the company goals.

·               Managed a mid-size development team consisting of junior managers, architects, team leads and software engineers. Managed both employees and consultants. The team members were located globally in US, UK and Japan.

·               Collaborated with the global QA department for compliance with different regulatory body requirements such as FDA and MHRA.

·               Key activities include managing project scope, requirements gathering, risk management, hiring employees to support company growth, conduct product architecture and design session and supervise the direct reports.

·               Participated in producing product roadmap working with the executive management team to keep the company ahead in the market in the difficult financial times.

·               Collaborate with training and technical communications department to make them aware as well as helping them to document the product features in our offerings to help our customers.

Key Accomplishments:

·               Successfully delivered 4 new releases of the Medidata Rave product leading the development efforts on many improvements and additions on the EDC software. All releases were made within the expected time and budget constraints aligned with the project scope.

·               Pioneered some critical EDC features not found in other software products in the market and that contributed to significant sales growth for the product.

·               Established many work standards and architectures to save development time and help future agile developments. Followed strict standards of the regulated industry.

·               Pioneered the new Medical Coding Software development for the company that is expected to become the best of breed software in this market segment.

·               Participated in many external company forums such as taking part in DIA and Customer Advisory Board.

·               Actively participated in the core M&A team to make the first successful acquisition for the company.

·               Successfully participated in pre-sales activities helping RFP responses and customer presentation winning some major contracts from companies like EISAI (Japanese Pharmaceutical) and supporting business for J&J, Amgen and so on.

MarketRx, Bridgewater, NJ2004 – 2005

Development Manager

Summary:

·               Manage product development and assist the pharmaceutical market research campaigns launched by the company.

·               Collaborate with professional services team to satisfy the sophisticated campaign needs of global pharmaceutical clients launching new and prospective products' market research campaigns.

·               Periodic executive reporting on project status, risks and their mitigation plans.

·               Plan ahead for the future development effort of the company.

·               Manage a mid-size team of direct reports located in US and Indian Offshore Center.

·               Collaborate with IT Services to facilitate smooth operation.

·               Collaborate with SMEs on specific market research needs.

Accomplishments:

·               Supported tens of successful market research campaigns from most of the big pharmaceutical clients across the globe. These activities contributed to the 75% of the total revenue of the company at that time.

·               The offshore outsourcing model needed a desperate streamlining when I joined as the outsourcing was not being time and cost effective due to lack of effective management controls. The whole operation was streamlined within a few months to make them operationally effective and profitable. The offshore team finally became a dependable team.

Data-core Systems, Philadelphia, PA2000 – 2004

Project Manager

Summary of Engagement

·               Worked as the practice lead for all Microsoft Technology based turnkey projects executed by the company. Responsible for complete Requirements Analysis on the turnkey projects and prospects for the company.

·               Worked as a Technical Architect on many projects executed by the company.

·               Supervise a mid-size team of developers onsite and offshore.

·               New business development working with the sales force.

 

 

 

Infosys Technologies, US & India Operations              1995 – 2000

Technical Account Manager

Summary of Engagement

·               Responsible for end-to-end project management for the turnkey projects taken up by my team.

·               The team was mostly India-based offshore development team with a few junior architects and project leaders in the US under my supervision. Work as the principal architect for the most challenging ones of the projects executed.

·               New business development working the sales team.

·               Delivered 5 projects for Owens in Ohio on time and budget with the offshore development team.

·               Participated in the company's standardization process that earned the company CMM Level 5 certification at a time when few companies in the world could achieve that.

HMT Limited1991 – 1995

Engineer

·               Development of Computer Integrated Manufacturing System pioneered by this company in India for the first time in the country.

·               Management trainings received as organized by the company.

·               MBA, Rutgers Business School, NJ

 

·               ITIL Foundation V3 (Certified by APMG, UK)

·               Statistical Reasoning for Public Health, delivered by Johns Hopkins University

·               Content Strategy for Professionals, delivered by Northwestern University

·               Design and Interpretation of Clinical Trials, delivered by Johns Hopkins University

·               Mathematical Biostatistics Boot Camp delivered by Johns Hopkins University

·               High Performance Scientific Computing, delivered by University of Washington.

 

·               Trained at work on Contract Management, Project Management, SharePoint Administration, 508 Remediation, SQL Server SSIS and MVC with MS .Net, Training courses for COR certification, Big data development with Hadoop.