Sr. IT Project Manager AI/AWS, Regulated Sectors

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PROFESSIONAL SUMMARY

Agile Sr Project Management with extensive expertise in AI/AWS cloud computing & architect, security and compliance within the Finance, Pharmaceutical, Biotech, LifeScience and Healthcare domains. Adept at leading cross-functional teams and managing complex AI/AWS IT projects, consistently driving innovative solutions that enhance organizational success. Committed to leveraging cutting-edge AI technology and strategic insights to achieve measurable outcomes and propel future advancements in project management. Agile product development and project management experience. Strong background in product management, Pharma, Biotech, Stem Cell banking, healthcare technology & SaaS platforms. Ability to work independently with significant latitude in determining objectives and approaches. Aligned strongly with hybrid profile spanning IT Solution Delivery, validated systems support, business analysis, vendor management, and emerging AI governance within a regulated Pharma/Biotech environment.

Experienced Senior IT Project Manager with 10+ years leading complex enterprise application development and system integration initiatives using structured Waterfall methodology. Proven track record managing full Project Management Life Cycle (PMLC) and Systems Development Life Cycle (SDLC) phases from initiation through post-implementation support. Strong expertise in scope control, budget management, vendor governance, audit compliance, and stakeholder communication within regulated environments including Commercial Insurance.

Sr. IT Project Manager: Application Development System Integration Waterfall Delivery PMLC SDLC

Integration Program Management Engagement Scope & Delivery Framework

Engagement Initiation & Scoping: Conduct kickoff sessions with Client and Partner stakeholders to validate: Integration scope Governance expectations Delivery priorities Coordination and operating model

Align on: Project management methodology and processes Reporting structure and cadence Escalation procedures ServiceNow workflow expectations supporting integration activities

Identify: Executive sponsors and key stakeholders Business and technical owners Cross-functional coordination points across current and future integrations

Integration Planning & Governance: Establish governance structure including Steering committees Working groups Milestone and delivery framework Reporting cadence Stakeholder communication model

Define: Integration planning assumptions Dependencies and risks Resource coordination requirements Cross-functional engagement model Confirm project management support expectations including Governance meeting facilitation Status reporting Timeline and milestone tracking Risk and issue management Executive communications and updates

Execution Coordination & Delivery Support: Coordinate across business and technical workstreams to support: Integration execution Stakeholder alignment Issue resolution Project tracking and reporting Facilitate collaboration between North American and Partner stakeholders to maintain alignment on: Integration activities Governance standards Delivery expectations Support onboarding and execution within the Client’s: SNOW-driven project management environment Standardized governance and compliance framework

Key Deliverables

Integration of governance framework and stakeholder mapping

Project management and reporting structure aligned with SNOW requirements

Integrated project plan with milestone tracking and coordination model

Escalation management, issue tracking, and stakeholder communication framework

Engagement Assumptions

Client and Partner stakeholders will actively support onboarding and coordination activities

Existing governance documentation, workflows, and SNOW processes will be provided

Initial engagement scope will focus on the Color WOW integration, with potential expansion to future integrations

Hybrid coordination across U.S. and global teams will be required throughout the engagement lifecycle

Engagement Objectives

Confirm integration scope, stakeholder alignment, and governance expectations

Align project management processes, reporting standards, and SNOW workflow requirements

Establish integration planning assumptions, coordination framework, and delivery priorities supporting successful execution

Project Management & Delivery

Led end to end project lifecycle ensuring delivery within scope, schedule, budget, and quality objectives

Apply standardized methodologies to manage scope, timelines, costs, and overall project governance

Track and report project progress, proactively identifying risks, issues, and dependencies to ensure on-time, on-budget delivery

Ensure alignment of project outcomes with business objectives and measurable value realization

Change Management

Support development and execution of change management strategy, including detailed plans and work breakdown structures

Define and track change metrics to assess adoption, effectiveness, and business impact

Facilitate process impact discussions and coordinate Subject Matter Experts to support change initiatives

Stakeholder Management

Identify, analyze, and manage stakeholders based on influence, impact, and level of support

Partner with Project Leaders and cross-functional stakeholders to align expectations and mitigate risks

Drive stakeholder engagement strategies, including leadership alignment and action planning

Communication & Reporting

Develop and execute project communication strategies, messaging, and delivery plans across defined channels

Conduct pulse surveys and feedback mechanisms to measure awareness and communication effectiveness

Maintain and update project dashboards, charters, milestones, and risk logs on a regular cadence

Governance & Coordination

Plan and facilitate project meetings, including steering committees, and document key decisions and action items

Coordinate cross-functional teams and internal resources to ensure alignment and timely issue resolution

Ensure all project deliverables are completed and formally closed in project management systems per charter and contractual obligations

Validated System Delivery: Experience with GxP/validated systems Working with QA/CSV teams Change control participation Traceability and documentation discipline UAT coordination SOP adherence Audit readiness Medical Affairs systems Clinical systems R&D platforms Safety/pharmacovigilance platforms Content management systems Analytics/reporting platforms

Application/System Ownership: Enhancement coordination Incident/problem management SLA tracking Vendor escalation management Release coordination Upgrade support Hypercare activities Governance meetings Operational reporting

Vendor Management: Managing SaaS vendors Reviewing support performance Escalation handling Contract/license coordination

Renewal planning Reviewing AI vendor claims Managing implementation partners

AI / Generative AI Readiness: Prompt engineering familiarity AI-assisted analysis Responsible AI usage Traceability of AI outputs

Human-in-the-loop controls AI vendor assessment Governance awareness Data science ML model development LLM fine-tuning Python AI engineering

Business Analysis & Delivery Coordination: Requirements gathering User story documentation Workshop facilitation RAID management Milestone tracking Dependency coordination Executive/status reporting Cross-functional communication IT Delivery Lead Solution Delivery Manager Business Systems Lead Technical PM / Functional PM Application Manager Pharma/Biotech enterprise systems R&D or Medical Affairs applications Validated SDLC delivery Cloud/SaaS implementations

Vendor governance PMO leadership IT business partnership Risk/compliance coordination AI-enabled operational transformation

Validated systems GxP QA/CSV Change control SDLC SaaS platforms Vendor management SLA management Hypercare UAT coordination Requirements gathering RAID logs Medical Affairs systems R&D systems AI governance Prompt engineering Human-in-the-loop validation Compliance and audit readiness Integration coordination Operational support System lifecycle management.

Platforms / Ecosystems: Veeva Salesforce Health Cloud Med Comms systems Medical Information platforms Safety systems RIM/document platforms Analytics/reporting tools Power BI/Tableau ServiceNow/Jira SaaS integrations AI copilots and enterprise LLM tooling

Operational Support: Managing production incidents SLA governance Vendor escalations Coordinating releases/upgrades

Validation & Compliance: Working with QA/CSV Audit support Validation documentation Change control processes

Delivery Leadership: Cross-functional coordination Managing timelines/dependencies Stakeholder communication Hybrid Agile/Waterfall execution

AI Governance: Evaluating AI tools Data privacy concerns AI traceability Human review processes Prompt engineering examples

Vendor Evaluation: SaaS assessment criteria Security/compliance review Scalability analysis Operational readiness evaluation

CORE COMPETENCIES: Waterfall Project Delivery Agile & Hybrid Delivery Models Project Management Life Cycle (PMLC) Systems Development Life Cycle (SDLC) Enterprise Application Development Data Integration & API-Based Architectures Risk & Issue Management IT Governance & Audit Compliance Vendor & Contract Management Executive Status Reporting MS Project, Planview, SharePoint Budgeting & Financial Forecasting Led full lifecycle replacement of legacy policy administration system with integrated underwriting and claims modules Own and support Medical Affairs/R&D applications Coordinate vendors and business stakeholders Deliver validated projects in regulated environments Support SaaS platforms and integrations Participate in QA/CSV and compliance processes Introduce and assess AI-enabled solutions responsibly Operate effectively in cross-functional pharma environments IT Solution Delivery Business Systems Ownership Validation/Compliance Coordination Vendor & Operational Governance AI-enabled process modernization

EMPLOYMENT HISTORY

Apellis, Remote, PMJan 2023 - Dec 2025

As a Digital AI Product Management / Solution Architect owned and managed Clinical, R&D and Commercial product vision, roadmap, and scope of work. Develop a deep understanding of the business case, desired future state, and value drivers. Leverage knowledge of the digital product value stream and system interactions to identify when new features or changes are required to achieve business outcomes for the Products includes CTMS, SAS, ServiceNow, Veeva, Smartsheet, Jira & etc. Break down complex problems and business asks into clear, well-structured requirements and features. Facilitate regular backlog grooming and refinement sessions. System validation activities and ensure delivered solutions meet functional and non-functional expectations. Owned, maintained Content management repositories/files/structures using Veeva Vault. Self-starter, leadership, negotiation, stakeholder management, communication (written & verbal skills), collaborate effectively with tech & non-Tech owners, analytical, problem-solving, time oriented, and managed multi priorities in fast-paced organizations. Developed, managed project plans & deliveries for AI/AWS IT applications. Managed AI/AWS SAS Tools/ServiceNow ITIL projects. Act as the central communication point between stakeholders, vendors, users & cross functional teams.

Own the core SNOW ITSM module product vision and roadmap (Incident, Problem, Change, Service Catalog, Knowledge, SLM, Asset, CMDB). Act a POC for ITSM, ITOM, ITAM, CMDB & Employee center capabilities. Align SNOW enhancements with ITIL best practices. Continuously identify opportunities to improve service delivery, user experience, and operational efficiency.

Managed SNOW product & backlogs in various ITSM modules, including Incident, Problem, Change, Request, and Service Catalog for the key business applications with ITIL principles and IT service management with laboratory, R&D, Clinical, QA, QC, Commercial & manufacturing operations. Expose in SNOW modules including CSDM, Discovery, Performance Analytics & ATF. Experience with Agile, Scrum & Waterfall delivery methodologies using Jira. Documented SNOW modules and build Visio diagram for workflows, decision making chart, integration & etc.

Eisai, NJ, Sr PM Jul 2020 - Dec 2022

Develop and manage AI/AWS Cloud-Migration project plan; Migrated 500+ Oncology (Active, Archive & Legacy studies). A duration of 36 months. Clinical system studies data migrated to latest build SAS AI/AWS cloud environment which includes project plan, resource, data mapping, file transfer, ServiceNow ITIL, Change Control, Release, accounts, study partners, sftp setup, UAT, GxP validation deliverables, vendor management, QA & QC tasks.

Managed ServiceNow product backlog using ITSM, ITOM, ITAM & CMDB modules (Incident, Problem, Change, Request & Service Catalog) with understanding of ITIL principles and IT service management best practices. Update & Maintain CMDB data for continuous improvement process. POC for inquires, maintenance for product catalogs. Utilize Software Asset Management to monitor usage and maintain compliance. Configured the workflow for the ITSM module. Managed SNOW ITAM module to add, modify, review and delete IT asset related to hardware, software, licenses, electronic devices, cloud asset. contracts, forecast, schedule maintenance and identify assets not used or underused. Consolidate asset data to ensure accuracy and improve decision-making. Link ITAM with ITIL processes like Change & Incident.

Experience in migrating SAS, Pace, and Jreview to version upgrade. Build comprehensive plans for migration, execution, identifying and mitigating risks. Solid experience maintaining the AWS SAS & Supply-Chain platform and associated 3rd party systems. Strong knowledge & managed the AI/AWS, RDBMS & infrastructure process. Liaison between internal stakeholders and external customers. Deep business & pharma knowledge to manage and develop Visio flow diagrams for Validation.

HCL, Remote, LeadJan 2020 - Jun 2020

Documentation Management System - Plan, design, requirements, validation, test cases, integration, deployment of the documentation management system for multiple applications. Technology: AWS, Service Now, MS Office & Share point.

Intercept, NYC, Lead Oct 2018 - Jun 2019

HR & Facilities - Provide IT solutions to the HR department from hiring till retirement process. Involves design, planning, requirements, develop, configure, test, implementation, deliver onboarding to retirement stages for the HR systems/ technology. Prioritize features and enhancements based on business impact, customer feedback, and technical feasibility. Work closely with HR and other depts and teams for business requirements. Tracked project tasks and deliverables using Microsoft Project management tool and delivered multiple reports like Gantt. Facility Ticket Tracking Management System - Plan, design, requirements, validate, test cases, integrate, deploy the iOffice application for multiple locations (USA and UK). Integrated with Service Now using API interfaces.

Celgene, NJ, Lead/Sr System AnalystMar 2011 - Aug 2018

Development/Data Analytic Design, Develop & customized pharma applications to custom needed support the Pharma business team like medical affair, Drug safety, Customer Service, Facility, HR and other departments. Migrate data from legacy systems into middleware and upgrade applications. Databases and applications migrations, analysis data between applications, databases and file systems/servers.

Veeva /Salesforce Migration - The SalesLogix CRM migrated to Salesforce. The migration initiative was handled by vendors, offshore and onsite teams for LifebankUSA.com. Veeva Vault - System and client configuration through establishing document types, fields, lifecycles as well as supporting automation through workflows and notification management. Supporting Clinical and Regulatory users managing regulatory binders, submissions, and electronic Trial Master Files (eTMFs).

CRM ERP LIMS Lab Devices - Managed, deployed, migrated, delivered & decommissioned Oracle ERP, Financial, JIT, Impresa, CRM Salesforce, SalesLogix, Veeva, Matrix & Abott lab medical devices. Setting up Stem lab (Placenta and Umbilical cord) Stem Cell banking count processes, maintenance, patches, upgrade with CRM systems. Created and executed IQ/QO/PQ/SRS/URS and validation deliverables. Yearly maintenance, patches & upgrades. Worked with Abott device vendors, lab integration, Stem Lab applications vendors for installation and maintenance and integration. Managed multiple lab devices and equipment with both internal and external partners and vendors. Devices & equipment’s upgrade like software, hardware and API integrations with Database, middleware, application and other outside client set up. Disaster recovery process for CRM, EPR, Lab Medical devices and equipment’s are involved in this process. Create, maintain, process LIMS regulatory file structures through Share Point and Content file management systems. Migrated Content file management file servers into latest build Share Point for LIMS & Medical Affairs Matrix system.

Service Now - Managed, worked & delivered on modules such as Work Management IT Service Management (ITSM), covering incident, problem, and change management; IT Operations Management (ITOM), for managing infrastructure and cloud operations; IT Asset Management (ITAM), to track hardware and software assets; HR Service Delivery (HRSD), for employee HR processes; Security Operations (SecOps), to manage security risks; Strategic Portfolio Management (SPM), for managing projects and portfolios; and Customer Service Management (CSM) and CMDB to maintain data, configuration and processes.

Website Deployment - Spearheaded LifebankUSA website and integration projects that required website hosting with an outside vendor, monitoring project control for business team, oversight of integration and implementation of SalesLogix, Stem Lab, Solomon, and website site deployment. Managed, deployed, delivered the Abott lab medical devices, setting up Stem lab (Placenta and Umbilical cord) Stem Cell banking count processes, maintenance, patches, upgrade and etc. Created and executed IQ/QO/PQ/SRS/URS and validation delivers. Yearly maintenance, patches & upgrades. Worked with Abott device vendors, lab integration, Stem Lab applications vendors for installation and maintenance and integration.

Technology - Unix Pearl scripts C SFTP & FTP Java J2EE Hibernate Springs Struts Servlets XML PHP VB VB scripts PHP Oracle SQL PL/SQL Forms Reports Pro*C SQL Loader Oracle Database Matrix Blueprint IRise ServiceNow ITSM reporting SalesLogix Solomon Stem Lab IDMP MODA HP ALM Concerto DTP Subversion Reference Manager AWS/Cloud Veeva Salesforce SAS JIRA Jreview Reference Manager Review-please InForm Central Designer & Coding Medidata RAVE IRT RBM PACE Pinnacle 21 QMS EQMS LIMS CTMS/Clinical Product Study SAP Concur SIEBEL Facilities/Chemical Tracking System CRM ERP LAB systems Clinical DW/OBIEE SharePoint ServiceNow Publishing Systems QMS Track-wise CTD eCTD Parexel Rees Clinical and Safety Data ware systems.

Celgene Cellular Therapeutics/Stem Cell Banking, NJ (http://www.LifebankUSA.com), Lead May 2006 – February 2011

Website Management - Developed, design, updates, and support of company website. Collaborated with multiple departments to upgrade sites and integrate other applications to optimize efficiency. Effectively administration & supported at the LifebankUSA stem cell bank facility. Ensured compliance with all CCT standards HIPAA, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements.

Managed, deployed, delivered the Abott lab medical devices, setting up Stem lab (Placenta and Umbilical cord) Stem Cell banking count processes, maintenance, patches, upgrade and etc. Created and executed IQ/QO/PQ/SRS/URS and validation delivers. Yearly maintenance, patches & upgrades. Worked with Abott device vendors, lab integration, Stem Lab applications vendors for installation and maintenance and integration. Create, maintain, process regulatory file structures through Share Point and Content file management systems.

Technology - Java, J2EE Cutting Edge Technology, Hibernate, Springs, Struts, Servlets, XML, PHP, VB, VB scripts, SalesLogix Solomon, Stem Lab, IDMP, LIMS, ServiceNow, Share Point, Content file management, Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Oracle Designer, UNIX, LINUX & Pearl scripts, C++, SFTP & FTP

Celgene, NJ Consultant February 2005 – April 2006

IT Projects - Managed design & deploying an order management system (COMS_OP), reports system (CRS), integration of finance business codes in the C4 system, software source control system & Req-Pro systems.

Provided technical support, collaborated with multiple departments like finance, customer care & Sharp Track project tasks and multiple roles and responsible using MS project tool as a project deliverable.

Compliance - Ensured compliance with all CCT standards HIPAA, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements for the biopharmaceutical industries. Managed documentation and validation of documents.

Education: Bachelor (Computer Science Engineering), Madras University, India.

Courses: Agile Scrum AI & GenAI CPMAI Value Stream Cloud Business Architect AI Infra & Construction Oracle Applications 11i Microsoft ASP .Net & Microsoft Project ETL Process Java Sapphire 4.5 LIMS Validation Deliverables CSV GxP CFR 21-part 11 CAPA FDA SOX SOP SOW QA & QC Sybase RDMS Oracle SQL Server MS Access Mango Apache Hive Big Data

Skills: AI Gen-AI Machine Learning Deep Learning NLP Computer Vision Cloud Computing AWS Big Data Tools SDLC Scrum Agile Waterfall Compliance Cloud-Migration API Middleware Configuration Project Management Program Management Product Management Risk Management Solution Architecture ERP Supply-Chain CRM Web Development Digital IT Visio Lucid Smart sheet Office 365 PowerPoint Python PySpark IoT FTP & SFTP Java XML HTML Unix Pearl scripts C++ Java J2EE PHP Oracle SQL PL/SQL Forms Reports Pro*C SQL Loader Oracle Database Matrix Blueprint IRise ServiceNow ITSM reporting IDMP MODA HP ALM Concerto DTP Subversion Reference Manager AWS/Cloud Veeva Salesforce SAS R Jira Jreview Reference Manager J Review InForm Central Designer & Coding Medidata RAVE IRT RBM Pace Pinnacle 21 QMS eQMS LIMS CTMS Clinical Product Study Sibel EHS Facilities & Chemical Tracking System LAB systems Clinical DW/OBIEE SharePoint Publishing Systems Track-wise CTD eCTD Parexel Rees Clinical & Safety Data ware systems OBIEE

Reporting Tools- BI tools Qlik Tableau Teradata SAS BI Oracle BI & MicroStrategy.

Certificates: CSM (Certified Scrum Master) CSPO (Certified Scrum Product Owner) A-CSPO (Advance Certified Scrum Product Owner) PMI-AI Prompt Engineering

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