Management Project

Sahil Chopra

** ****** ****, **** *******, NJ ***20

609-***-****, ***********@*****.***

SUMMARY:

Project/Product Management professional with more than 9 years of experience working in the pharmaceutical and medical imaging industries.

Extensive background in leadership, budgeting, product management, project management, business analysis, software development management, developer supervision, resource management, and documentation.

Expertise in project planning/prioritization, road map development, creation of work plans, capacity planning, risk analysis, risk mitigation, conflict management, envisioning solutions and following-up efficiently.

Experience working with cross functional teams to realize projects from concept to reality within allocated budget. Proven ability to develop product and marketing strategies and effectively communicate recommendations to executive management

Quick at grasping new concepts, technologies, processes and methodologies.

Extensive knowledge in all phases of software development (SDLC), Agile(Scrum sessions, Sprints) and waterfall methodologies, FDA Compliance, and 21 CFR Part 11 compliance along with CAPA management.

Demonstrated experience in establishing processes and implementing process improvements to achieve efficiency leading to cost benefits and strong ROIs.

Well experienced with Clinical trial workflows, Clinical software packages, and Clinical data management procedures.

PROFESSIONAL EXPERIENCE:

BioClinica, Inc., Princeton, NJ 04/2015 – 02/2016

Product Manager (Technical)

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

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

Evaluate promotional plans to ensure that they are consistent with product line strategy and that the message is effectively conveyed.

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.

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

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

Facilitated customer requirement gathering dialogs and request reviews.

Created and Implemented system/technology retirement plans for proper sun setting of products ensuring compliance with company SOPs and CAPA creation and management when needed.

Worked with product development to develop release plans detailing deliverables, schedule, features, and benefits.

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.

BioClinica, Inc. (formerly CoreLab Partners, Inc.), Princeton, NJ 01/2012 – 03/2015

Technical Project Manager, PMO

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

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 issues 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.

Interacting and presenting to all levels within the organization: Tracked project status and reported progress and milestones to stakeholders and management in different forums.

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.

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.

Projects:

* Audit Trail system: Launched and led a high priority project aimed at developing an audit trail system to provide an audit trail for all existing read data to address FDA findings resulting from an FDA facility inspection. Completed the project in the record time of 2 months from initiation to deployment.

* Integration projects: Executed enterprise-wide integration projects to eliminate paper and manual data entry. Led and managed a team of business analysts, developers, testers, and validation engineers involved in developing and testing software applications for integration of CTMS application with image reading system and integration of image reading system with Oracle Clinical.

* CVS Data Utility: Initiated and executed implementation of an application to alleviate the workload of production support tickets by providing the ability to users to perform tasks related to DICOM images reducing the workload on support by 80% for these tasks and increasing efficiency.

CoreLab Partners Inc., NJ (formerly RadPharm, Inc.), Princeton, NJ Nov 2008-Dec 2011

Lead Integration and Test Engineer (Consultant)

Project lead and Business analyst for various imaging projects.

Defined User requirements for Imaging applications, UI design, Software Design & Architecture.

Communicated with vendor(s) directly for development, testing and delivery of product level releases.

Defined workflow based use cases, testing strategy and managed testing/validation for various applications within imaging solutions.

Subject Matter Expert (SME) and Final tier of support for Imaging Applications and integrated systems.

Projects:

* Medical Imaging application: An advanced imaging application for reading, annotating and creating 2D and 3D measurements on single and multi-frame images for different imaging modalities including CT, MR, PET, and Ultrasound for clinical trials.

* Worklist Creation application: An application for serving tasks to medical image reading application providing an interface between the workflow system and the image repository.

* Clinical Trail Workflow Management system: A Siebel based customized solution for tracking and reporting of clinical trial data.

Mindlance Inc., NJ Aug 2006-Nov 2008

Lead Validation Engineer, Pharmaceutical Imaging Core Lab client

Involved in lifecycle management of enterprise-wide core systems and processes that support the daily operations of radiology lab these include acquisitions, quality control, reading of radiographic images, de-Identification of private patient information.

Managed validation project deliverables, timelines, work streams, and resources from analysis to deployment. Created work breakdown structure, project plans, test plans, estimations, attended hands-off meetings, and maintained status reports.

Managed authoring, review, and approval of Validation documents: Validation plans, SOPs, Requirements, Qualification protocols, Summary Reports, CAPA, and Release notifications.

Worked closely with Development team, Data management, and clinical specialists to validate the functionality and defects for each new release.

EDUCATION:

Master of Science - Electrical Engineering (MSEE), San Jose State University, CA.

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