SUMMARY

• A result oriented, knowledgeable IT Project Manager with 19 years of experience in Project Management, Program Management, Infrastructure Management, IT Service Management and Business Analysis. Successfully led, planned/ coordinated/ managed/ delivered full lifecycle development and implementation of software projects, infrastructure upgrade projects, COTS implementation / ERP projects within given scope, timelines, resources and applicable quality standards across different industry domains for different business verticals with onsite and offshore teams.
• Worked with developers and other IT administrators to architect scalable and reliable web systems, and resolve issues using Cloud, SEO and other externally hosted solutions.
• Expertise in Primavera P6 (incl. Methodology Management, Portfolio Analysis), MS Projects Professional 2010 (and earlier versions), SharePoint etc.
• Totally conversant with PMI PMBOK ® Guide (Project Management Body of Knowledge Guide), hands on experience of PERT, CPM, Networking Techniques, Precedence Diagramming Methods. Excellent Project Management skills in large enterprises in US, Europe, India, managed multimillion dollar projects with internal, external customers, 25+ (average) team members (onsite, offshore including vendor resources in different Time zones) of multi - cultural / multi linguistic background with abilities to see things from a Customer Standpoint.
• Depending upon the scope, timelines, criticality, and resources’ availability for each of the software development projects, adopted various Software Development Life Cycle methodologies such as Waterfall, Cascading Waterfall, Agile or customer tailored methodologies.
• Program / Project management expertise includes areas of Project preparation, Technical strategic planning, Discovery, Business Process Mapping, Requirements collection, Analysis, Design, Development, Integration, Configuration, Testing and QA, Release management, Deployment management of Application Development or Infrastructure Upgrade Projects in cross-domain matrix business environment.
• Knowledgeable of ‘ITIL - Concepts & Techniques’, ITIL best practices. Trained on Service Center, Incident Management, Change Management, Problem Management, Asset Management, Configuration Management, CMDB, Knowledge Management etc. Working experience of different modules of ServiceNow.
• Worked on Applications for large Pharmaceutical Co. in regulated environment, compliance to HIPAA, USFDA,EMA,CHMP regulations including but not limited to 21CFR Part 11 - Electronic Records, Electronic Signatures, 21 CFR 312.23 - Investigational New Drug (IND) application . Knowledge & experience of overall Drug development Process, IT Applications / COTS solutions used in the R&D, Biologics, Biostatistics, Drug Marketing, Regulatory Submissions, Drug Safety & Epidemiology organizations of large Pharmaceutical companies (including CROs, CMOs, Strategic Business Partners). Experienced working in a GxP validation environment.
• Overall knowledge of COTS offerings from Oracle Health Sciences, Liquent Insight Suite, eCTDXPress, Documentum/D2, QUMAS DocCompliance, Nextance Contract Insight, Medidata Rave, QM Scoring etc.

PROFESSIONAL EXPERIENCE:

Confidential, MI

Sr. Project Manager

Responsibilities:

• Preparation of a detailed Project Execution Plan in MS Projects 2010 including baseline schedule, Resource plans etc.
• Coordinate CMDB Design workshops.
• Work with respective Product Owners for functional requirements within ServiceNow for Request Management, Incident Management, Problem Management, Change ManagementKnowledge Management, Core Platform, Web services, interfaces etc.
• Coordinate, design and engineer solutions leveraging all appropriate components offered by ServiceNow to meet needs for business workflows, ticketing best practices and other ITSM requirements.
• Production Release Planning including Dry run, backup, cloning, release management.
• Coordinate Organizational Change Management Activities including focus groups, early adopters, training, communication.
• Coordinate defect fixes with Development team for defects identified during testing, Production Dry run.
• Played the role of Scrum Master with corresponding responsibilities.
• Vendor invoice review/ assessment, budget tracking etc.
• Provided oversight for ServiceNow PPS solution implementation.
• Led designing, establishing Governance Processes, SOPs, Support model for Pre and Post Go Live phases.
• Coordinated testing, roll out of ServiceNow mobile app.

Confidential

Program Team

Responsibilities:

• Preparation of a detailed Project Execution Plan in MS Projects 2010 including baseline schedule, Resource plans, Infrastructure Provisioning, Build, Delivery etc.
• Interact regularly with Business, Operations teams, to facilitate understanding/ discovery/ requirements gathering, work as a bridge between business, vendor and IT solution engineering, project implementation, interface application support teams and Regulatory Compliance teams.
• Understand AS - IS and TO - BE state business processes, Mapped AS-IS and TO-BE business processes and provide leadership as an IT functional subject matter expert (SME).
• Leverage SharePoint features effectively for registering, tracking Action items, Issues, Risks, Decisions, Review/ Approvals/ Archival of LCM artifacts etc.
• Provide Sponsors, Program Management Office with regular status updates, weekly scorecards.
• Organize, participated in bi weekly IT Governance meetings, Weekly WS Leads Review Meetings, Business Process Review/ Analysis meetings. Also conducted Alignment workshops with different teams, vendors (like CSC, Randstad).
• Risk Identification / Profiling, Mitigation strategies, measures.
• Using SharePoint, collaborate and drive the Integration component development and delivery working closely with Integration development team, Middleware component development team, IT Validation team and Vendors.
• Work with Compliance (OGC), IT Security, Validation Services teams for Regulatory Assessments, Security Review.
• Coordinate deployment activities working closely with Infrastructure team, release management teams.

Environment: ServiceNow ITSM Solution, ServiceNow PPS Solution, MS Project 2010, MS Office, SharePoint, HP Quality Center.

Confidential, NJ

Sr. Project Manager

Responsibilities:

• Preparation of a detailed Project Execution Plan in MS Projects 2010 including baseline schedule, Resource plans, Infrastructure Provisioning, Build, Delivery etc.
• Interact regularly with Business, Operations teams, to facilitate understanding/ discovery/ requirements gathering, work as a bridge between business, vendor and IT solution engineering, project implementation, interface application support teams and R&D Regulatory Compliance teams.
• Understand AS - IS and TO - BE state business processes, Mapped AS-IS and TO-BE business processes and provide leadership as an IT functional subject matter expert (SME).
• Leverage SharePoint features effectively for registering, tracking Action items, Issues, Risks, Decisions, Review/ Approvals/ Archival of LCM artifacts etc.
• Provide Sponsors, Program Management Office with regular status updates, weekly scorecards.
• Organize, participated in bi weekly IT Governance meetings, Weekly WS Leads Review Meetings, Business Process Review/ Analysis meetings. Also conducted Alignment workshops with different teams, vendors (like Oracle).
• Risk Identification / Profiling, Mitigation strategies, measures.
• Work with Regulatory Compliance, IT Security, Validation Services teams for Regulatory Assessments, Security Review.
• Coordinate activities with ITSM teams (Asset Management, Incident Management, Change Management etc.).
• Coordinate deployment activities working closely with Infrastructure team, release management teams.

Confidential, NJ

Technical Project Manager

Responsibilities:

• Preparation of a detailed Project Execution Plan in MS Projects 2010 including baseline schedule, Resource plans, Infrastructure Provisioning, Build, Test, Delivery etc.
• Collaborate with Clients’ business, product, IT teams and Third party vendors to deliver software solutions.
• Oversee Release Management activities including Issues, Risks and corresponding Mitigation Planning.
• Accountable for publishing Weekly Scorecards and Monthly Report (in terms of Schedule, Budget, Resources etc.)
• Monitor and document project status; anticipate / forecast Issues, Risks, problems and prepare mitigation plan / resolve or escalate them to the appropriate level of management for resolution in order to ensure proper project completion within schedule and budget constraints
• Successfully manage communications amongst Onsite, Offshore team members, Client functional departments, and to the Client’s end Clients, third party vendors.
• Change management, Coordinate User training, Post Go Live Support.

Confidential, NJ

Project Manager

Responsibilities:

• Oversee preparation of a detailed Master Project Execution Plan in MS Projects 2010 including baseline schedule, Resource plans, Infrastructure Provisioning, Build, Test, Delivery etc.
• Collaborate with Clients’ business, product, IT teams and Third party vendors to deliver software solutions.
• Oversee Release Management activities including Issues, Risks and corresponding Mitigation Planning.
• Provide necessary support to Development manager for scope estimation, feasibility and pricing.
• Understand, map AS-IS and TO-BE business processes using MS Visio and provide leadership as an IT functional subject matter expert (SME).
• Coordinate with all relevant stakeholders to sort out any clarifications regarding the project execution - right from FRD Clarifications to Timelines.
• Accountable for publishing Weekly Scorecards and Monthly Report (in terms of Schedule, Budget, Resources etc.)
• Monitor and document project status; anticipate / forecast Issues, Risks, problems and prepare mitigation plan / resolve or escalate them to the appropriate level of management for resolution in order to ensure proper project completion within schedule and budget constraints
• Successfully manage communications amongst Onsite, Offshore team members, Client functional departments, and to the Client’s end Clients, third party vendors.

Environment: Microsoft .NET Framework, Windows Server 2008, MS Project 2010, MS Office (incl. Visio), Axosoft Onetime, Documentum.

Confidential, NJ

Sr. Project Manager

Responsibilities:

• Oversee preparation of a detailed Master Project Execution Plan in MS Projects 2010 including baseline schedule, Resource plans, Infrastructure Provisioning, Build, Delivery etc.
• Review, Track / Monitor Project Plans for each interfacing application in light of Master Project Plan in MS Projects 2010.
• Oversee, coordinate design, development, delivery of new interfaces with Drug Safety System as “Packaged Solution” by well-known implementation partners/ vendors (combination of on site, offshore team members).
• Interact regularly with PV Business, Operations teams, to facilitate understanding/ discovery/ requirements gathering, work as a bridge between business, vendor and IT solution engineering, project implementation, interface application support teams and R&D Regulatory Compliance teams.
• Understand AS – IS and TO – BE state business processes, draft and coordinate Reviews and Approvals of Interface Integration framework, execution strategy documents, LCM artifacts.
• Using ARIS BPM tool, mapped AS-IS and TO-BE business processes, interfacing / peripheral applications and provide leadership as an IT functional subject matter expert (SME).
• Convert the Process requirements to Prototypes and screen flows for demonstration to business.
• Facilitate Solution Engineering of interfaces with ARGUS in a externally hosted multi- tenant environment.
• Leverage SharePoint features effectively for registering, tracking Action items, Issues, Risks, Decisions, Review/ Approvals/ Archival of LCM artifacts etc.
• Provide Sponsors, Program Management Office with regular status updates, weekly scorecards.
• Organize, participated in bi weekly IT Governance meetings, Weekly WS Leads Review Meetings, Business Process Review/ Analysis meetings. Also conducted Alignment workshops with different teams, vendors (like Oracle).
• Coordinate activities with ITSM teams (Asset Management, Incident Management, Change Management etc.).
• Coordinate deployment activities working closely with Infrastructure team, release management teams.

Environment: UNIX, Windows Server 2008, MS Project 2010, MS Office, ARIS BPM tool, Oracle ARGUS, BMC Remedy, Externally hosted multi- tenant environment, Oracle Argus Mart, Oracle Clinical, Liquent Insight Suite, eCTDXPress, Documentum/D2, QUMAS DocCompliance, Labeling Systems, Nextance Contract Insight, SharePoint, and HP Quality Center.

Confidential, NJ

Sr. Project Manager

Responsibilities:

• Prepared, implemented the Project Charter, Project Management Plan with scope, timelines, Organizational Structure with corresponding RACI charts, Tracking Lists, IQ OQ Plan, Release to Production Memo and other Project ELC artifacts.
• Preparation of a detailed Project Execution Plan in MS Projects 2010 (and MSP 2007) including baseline schedule, WBS, Budget, Resource plans, Implementation milestones, Risks’ Log & Mitigation matrix, Infrastructure Provisioning and Build etc.
• Interact with Business to understand business requirement and facilitate prototyping to conceptual model with screen flows, enable demonstration of the working concept and solicit feedback
• Understand/ review/ document AS-IS and TO-BE business processes using MS Visio and provide leadership as an IT functional subject matter expert (SME).
• Coordinate design, development, testing and delivery of new JReview (COTS product) by well-known implementation partner.
• Regularly monitor progress made on each activity by implementation partners/ service providers, track milestones using MS Projects. Identify schedule, budget variances and jointly plan, implement corrective actions with vendor.
• Used SharePoint as an Enterprise collaboration suite effectively for registering, tracking Action items, Issues, Risks, Decisions, LCM artifacts’ Review/ Approvals/ Archival etc.
• Provided Sponsors, Program Management Office with regular updates, weekly scorecards.
• Organized, participated in bi weekly Steering Committee meetings, Weekly Progress Review Meetings with Project Sponsors, Steering Committee members, different Project teams, conducted Alignment workshops, Linkage meetings including preparation of corresponding meeting notes with action items & parking lot.
• Definition, Alignment, Status Review of another initiative/ project under this Program for Service Development. Understand & follow FDA guidelines for R&D Regulatory Affairs applications.
• Regularly interact with SMEs from CMC Regulatory Submissions, Global Manufacturing and Supply teams for application enhancements, functionalities’ review etc.
• Initiation, Participation in Application specific Incident Management, Change Management, Release Management Processes. Initiation, participation in Asset Decommissioning / Retirement process.
• Identify, facilitate and coordinate impact analysis of this implementation on peripheral applications either legacy based or COTS based like Oracle CTMS, Oracle EBS.
• Monitor Server performance and advise suitable upgrade, capacity enhancement.

Environment: UNIX, Windows Server 2008, MS Project 2007/ 2010, MS Office (incl. Visio), HP Openview Suite, Oracle EBS, Java/ Advanced Java, BMC Remedy, SharePoint, HP Quality Center, SAS 8.2, SAS 9.1.3, SAS 9.2, QUMAS DocCompliance, Nextance Contract Insight, Amazon Web Services, TIBCO S+, HP Load Runner

TECHNICAL SKILLS

Languages: C, C++, Java 2, Visual Basic 6

Databases: FoxPro 2.5, MS Access, Oracle 11g, SQL Server 7.0, PL/ SQL

OS: MS DOS 6.0, MS Windows 9x / NT, MS Windows XP Pro, Windows 7, UNIX, Windows Server 2008 R2

Software Packages: MS Office 2007 / 2010, MS Visio 2007, MS OneNote 2010, MS Project 2010, Primavera P6

Internet Technologies: HTML, ASP, Advanced Java (JDBC, Beans, Servlet, XML, JSP, CORBA)RMI, EJB (J2EE), Web Services, SOAP, AWS

Packages: MS Office 2007 / 2010, MS Visio 2007, MS OneNote 2010

Web Design Packages: FrontPage 2000, Macromedia Dreamweaver, Flash

Web Server: IIS, Apache Web Server, Java webserver

Application Server: BEA WebLogic

Content Management: EMC Documentum

Performance Monitoring & Alerting Tools: HP Openview Suite, HP Sitescope, HP BAC, Compuware App Vantage, HP Performance Manager, Concord e Health, TelAlert, HP Operations Manager, Net scout.

ERP: SAP R/3, MBS Navision, Oracle E- Business Suite

Enterprise Collaboration Suite: SharePoint

Business Process Analysis, Management: ARIS, IBM BPM, Appian, Appway

ITSM: BMC Remedy (Asset Management, Incident Management, Change Management, Problem Management etc.), HP Service Manager. ServiceNow ITSM and PPS Tool.

Clinical Data Management, Trial Management: Oracle Clinical, Siebel CTMS, Oracle TMS

Pharmacovigilance and Drug Safety, Signal Detection COTS: Oracle Argus, Empirica Signal…

Business Analytics, Statistical Analysis: SAS 8.2, SAS 9.2

Cloud Computing: Amazon Cloud

Hardware: Intel 80x86, IBM PC-AT Compatibles, SUN SPARC Servers