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Project Manager

Location:
Cranbury Township, New Jersey, United States
Posted:
April 09, 2018

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Resume:

Bhavin Babaria M.S, PMP

Monroe Township NJ 732-***-**** ac42zm@r.postjobfree.com

Qualification Summary

Experienced project manager with overall 14+ years of successful managing and leading large IT projects

Developed detailed project plan, conducted project kick off meeting, responsible for communication management, stakeholder management, change management / risk management

Planned projects defining goals, schedule, scope / deliverables, and budget with values up to $6 million

Coordinated cross-functional teams up to a size of 30 in acquiring software and hardware resources, monitoring status, and controlling project changes

Own the requirements of the product, define the product roadmap based on the strategy and vision

Project experience controlling analysis, design, development, testing, and implementation phases

Managed Team of Business Analysts and Technical Writers

Reviewed/Created URS/FRS/SDS/UAT and setup process guidelines in compliance with GCP

Led/deployed numerous large implementations that the company has ever undertaken including the full integration of Siebel CTMS with Imaging Reading System and Oracle Clinical.

Defined functional and technical requirements, modeled business processes while applying structured and object-oriented analytic techniques

Thorough exposure of conducting JAD sessions and interviews with Subject Matter Experts (SME) and data stewards to understand the business process, business rules, and data requirements

Work History

WIRB COPERNICUS GROUP (WCG) MAY 2017 TO CURRENT

TECHNOLOGY DELIVERY MANAGER (WCG COPORATE IT)

Managed and delivered, multiple enterprise systems to all WCG business units.

Led all technology activities and integration services for four acquisitions.

Weekly IT PMO status meeting and generated weekly Technology dashboards for CEO, CTO and CIO review.

Planning, scheduling, and execution of all stages of software projects including initiation, development, testing, validation, and production deployment in a matrix organization.

Worked collaboratively with SMEs and customers to define product strategies, and requirements.

Managed validation and development teams as part of various large projects both onshore and offshore

Developed, maintained, and communicated project timeline and status to senior management, internal/external teams, and other stakeholders.

Worked with vendors and internal SMEs to finalize product

Created system proposals, feasibility / alternative analyses with software and hardware selections, performance and transaction analyses, Return of Investment and vendor qualifications.

BIOCLINICA INC. APRIL 2004 TO MAY 2017

PRODUCT MANAGER (ENGINEERING, APPLICATION DEVELOPMENT) BIOCLINICA INC. JUNE 2015 TO MAY 2017

Developed, maintained, and communicated product roadmaps to senior management, internal/external teams, and other stakeholders.

Extensive knowledge and expertise in the use of project management (Both Agile and Waterfall) and SDLC methodologies and tools.

Maintained complex product portfolio: Identified future product offerings and feature enhancements based on the competitive landscape, regulatory environment, and industry trends.

Led cross-functional and cross product efforts across product development, operations, sales, marketing, and support teams.

Successfully coordinated cross-functional teams to ensure corporate readiness in each department for new release launches.

Periodically presented to senior management and customers regarding the status, and plans for upcoming releases. (Collaboration technologies: SharePoint, Skype)

Demonstrated experience in documenting User Requirements/stories with prioritized features and corresponding justification; based on analysis of external and internal customer requests.

Demonstrated ability to manage multiple projects depending on each other as part of Oncology program.

Successfully delivered all projects on time with high quality within budget.

Facilitated customer requirement gathering dialogs and request reviews.

Exercised PMBOK knowledge and successfully delivered projects on time with high quality within budget.

Created and Implemented system/technology retirement plans for proper sun setting of products ensuring compliance with SOPs and GCP.

Supervised team of Business Analysts and Technical Writers.

Created quality gate checks for periodic updates and risk mitigation.

Contributed directly to development efforts by performing utility roles including project plan creation, status follow ups, requirements documentation, creation of user stories, facilitation, UI conceptualization, customer feedback sessions, and creating release notes.

Implemented projects using both waterfall and agile methodology (MS Project, Scrum, JIRA and Confluence)

TECHNICAL PROJECT MANAGER BIOCLINICA INC. MARCH 2013 TO JUNE 2015

Planning, scheduling, and execution of all stages of software projects including initiation, development, testing, validation, and production deployment in a matrix organization.

Defined scope of releases, product roadmaps; Prioritization across multiple projects based on company objectives and timelines.

Facilitated daily scrum calls to monitor status of individual sprints.

Demonstrated experience in resolving conflicts related to scope creep, risk assessment and mitigation, anticipation of project hurdles in advance (contingency planning) and providing solutions utilizing extensive business knowledge and negotiation skills.

Interacted and presented to all levels within the organization: Tracked project status and reported progress and milestones to stakeholders and management in different forums. Removed barriers and enabled team to complete release on time.

Introduced quality systems in various stages of project execution to enhance the quality of delivered projects.

Resolved resource issues by developing and implementing an outsourcing model, reducing the actual project cost and utilizing the same for future projects.

Demonstrated resource (on-site and off-shore) management for development, testing and validation activities for various projects.

Worked closely with various cross-functional teams: Development, Testing, Validation, Quality, Clinical Operations, Clinical Project Teams, Business Development and Medical Affairs both on shore and offshore (India, France, and UK).

Responsible for liaising between users, business owners and development team(s) for requesting features, enhancements and bug fixes; prioritizing based on time, effort, and ROI.

Provided demonstrations and training to Business Development personnel, users (internal and sponsor) on new features and enhancements, answering queries related to sponsor requests vs. system capabilities.

Managed and Lead quarterly web based and desktop applications development and release to production activities. Worked with teams both in house and offshore (India, Germany, and CA). (Mainly concentrated on Oncology Therapeutic area)

Followed various SDLC models during software development process (Agile (using JIRA/Confluence), Iterative, and Waterfall)

Authored and reviewed various documents: Project Charters, Project Plans, BRS, TRS, TDS, UAT Training Materials, and User Guides.

Chaired weekly JAD sessions for multiple application developments with both internal and external clients.

PROJECT MANAGER CORELAB PARTNERS INC. JANUARY 2010 – MARCH 2013

Managed complete integration project among Siebel CTMS (v8.0) system, Imaging Reading system and Oracle Clinical resulting in improved automation reducing manual processes and saved $700,000/year.

Managed and Led Siebel CTMS (v8.0) implementation which replaced existing Workflow Management System (WMS) resulting in stronger platform to support increasing number of studies and configurable workflows provided opportunity to grow in multiple therapeutic areas. Also, introduced expedited workflows, auto queries/issues raising leading to improved automation and reduction in manual processes and saved $500,000 / year.

Managed Image Reading System quarterly releases. (Validation team in India) resulting in faster image loading, performance improvements and more robust user interaction with the application resulting in faster turnaround of an imaging read and delivery to the sponsor.

Supervised team of Business Analysts and Senior Business Analysts.

Managed and Lead BA for Siebel Analytics reports implementation (OBIEE / ETL Informatica). Provided ability for ad-hoc reporting and dashboard for live reporting capabilities. Different turnaround time reports were developed which helped the company in identifying gaps in the business process and ad-hoc sponsor reports requests were fulfilled with this project resulting in sponsor trust and more studies for the company.

Authored various documents: Project Charters, Project Plans, URS, FRS, SDS, Validation Plan, Test Scripts, Validation Summary Reports, Training Materials, UAT, and Release to Production Memos, Training Materials, and User Guides.

PROJECT MANAGER RADPHARM INC. OCTOBER 2007 TO JANUARY 2010

Led a team of business analysts and was responsible for reviewing project requests, creating project plans, providing estimates for business requirements and functional design specifications.

Performed lead role in software gap analysis, ROI analysis and product selection. Heavily involved in selecting the Siebel CTMS product to replace the current Clinical Trial Management application.

Authored variety of documents including Project Charters, Vendor/Software Selection Reports, Change Request, URS, FRS, Use Case, Test Scripts, Val Plan, Val Summary and User Guides in compliance with 21CFRPart 11 regulatory environment.

Identified and organized project Steering Committee and Business Process Owner groups (SME’s) for all modules.

Chaired JAD sessions, created business architecture and process workflows for the Siebel implementation.

Worked closely with the project stakeholders in determining overall project strategy; coordinating systems and operational needs to support significant changes in products, policy, procedure or programs.

ASSISTANT PROJECT MANAGER RADPHARM INC. JANUARY 2006 TO OCTOBER 2007

Assisted in leading the design, documentation, implementation and management of clinical data collection reconciliation, review and reporting systems for FDA submission.

Managed timelines and delivered images and reports to FDA in submission package

Created regulatory reports using Microsoft Access, Oracle and Crystal Reports.

Created parameterized Crystal Reports from Excel application.

Executed UNIX shell scripts from command lines and helped Unix Programmer as needed.

Written URS/FRS/SDS, test scripts, process charters, UAT test scripts and SOPs.

PROJECT LEADER RADPHARM INC. APRIL 2004 TO DECEMBER 2005

Participated in the development and implementation of new processes and technology

Lead team of fifteen project coordinators

Troubleshoot image viewing application issues

Participated in new application features discussion

Managed schedules for 30 Radiologists

Prioritized work load based on timelines

DATABASE ADMIN, INTERN JOHNSON & JOHNSON (J&J) ORTHO-MCNEIL PHARMACEUTICAL MAY 2000 TO JAN 2001

EDUCATION

BACELOR OF SCIENCE (B.S) NEW JERSEY INSTITUTE OF TECHNOLOGY (NJIT) JUNE 2002

Major: Computer Science

Minor: Applied Mathematics

MASTER OF SCIENCE (M.S) NEW JERSEY INSTITUTE OF TECHNOLOGY (NJIT) JANUARY 2004

Major: Biomedical Engineering

Minor: Instrumentation (computer science)

CERTIFICATIONS

PMP (PROJECT MANAGEMENT PROFESSIONAL), PROJECT MANAGEMENT INSTITUTE (PMI) FEBRUARY, 2015

PUBLICATIONS

Babaria BR, Alvarez TL, Bergen MT and Servatius RJ. “Transmission of Light In a Synthetic Fog Medium,” 30th annual NE Biomedical Engineering Conference, Springfield, MA, 2004.



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