Hari Radhakrishnan
Piscataway
Summary
Experienced Senior Project Manager with expertise in AI and AWS cloud computing, architecture, security, and compliance in Finance, Pharmaceutical, and Healthcare sectors. Leads cross-functional teams to deliver complex IT projects and innovative solutions. Focused on utilizing AI technology and strategic insights to drive organizational success and advance project management initiatives.
Overview
21
21
years of professional experience
1
1
Certification
Work History
PM
Apellis
Remote
01.2023 - 12.2025
- Managed AI/AWS SAS projects across R&D, Clinical Operations, Regulatory Affairs, Quality Assurance, Manufacturing, and Commercial teams to ensure alignment and project goals.
- Develop and manage project plans & execution for ai/aws IT system ownership, oversight with laboratory, clinical & manufacturing environments.
- Define scope, timelines, milestones, and deliverables.
- Facilitated communication among vendors, business users, and internal stakeholders to enhance collaboration and streamline project processes.
- Identify risks early and implement mitigation strategies.
- Monitor project budgets, track costs, and allocate resources efficiently.
- Negotiate timeline and tasks with vendors, business users and IT teams.
- Managed deviations, CAPAs, and ensure timely issue resolution.
- Oversaw risk assessments and CAPA implementation.
- Defined and tracked KPIs to assess product success and adoption rates.
- Utilized project management tools like MS Project and Smartsheet for effective tracking.
- Implemented standardized PMO processes.
Sr PM
Eisai
NJ
07.2020 - 12.2022
- Experience in migrating SAS platform to newer versions, developing a comprehensive plan for migration, managing the execution of the migration plan, identifying and mitigating risks.
- Study Cloud-Migration - Migrated 500+ Oncology (Active, Archive & Legacy) Clinical system studies data to latest build SAS AI/AWS cloud environment.
- Developed GxP-based project plan encompassing resources, data mapping, file transfer, change control, study partner coordination, UAT, GxP validation deliverables, vendor management, and QA/QC tasks.
- Maintained AWS SAS and Supply-Chain platform to ensure operational efficiency.
- Oversaw AI/AWS and RDBMS infrastructure processes for system reliability.
- Facilitated communication between stakeholders and customers to ensure alignment on project goals.
- Led stakeholder negotiations to improve communication effectiveness across teams.
Lead
HCL
Remote
01.2020 - 06.2020
- Planned, designed, and validated documentation management system for multiple applications, including requirements gathering, test case development, integration, and deployment.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Executed daily operational tasks with precision in a fast-paced environment.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Executed daily tasks with precision and efficiency.
Lead
Intercept
NYC
10.2018 - 06.2019
- Designed, planned, developed, configured, tested, and implemented HR systems and technology for onboarding to retirement stages.
- 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.
- Planned, designed, validated, and deployed iOffice application for Facility Ticket Tracking Management System across multiple locations in USA and UK.
- Integrated with Service Now using API interfaces.
- HR & Facilities - Provide IT solutions to the HR department from hiring till retirement process.
Lead/Sr System Analyst
Celgene
NJ
03.2011 - 08.2018
- Led LifebankUSA website and integration projects, coordinating with external vendors for hosting and ensuring successful implementation of SalesLogix, Stem Lab, Solomon, and website deployment.
- Veeva /Salesforce Migration - The SalesLogix CRM migrated to Salesforce.
- Coordinated efforts of vendors, offshore, and onsite teams to successfully manage the migration initiative for LifebankUSA.com.
- Managed and deployed Oracle ERP, Financial, JIT, Impresa, CRM Salesforce, SalesLogix, Veeva, Matrix, and Abott lab medical devices, overseeing migration and decommissioning processes.
- Executed upgrades for devices and equipment, including software, hardware, and API integrations with databases and middleware.
- Disaster recovery process for CRM, EPR, Lab Medical devices and equipment’s are involved in this process.
- 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.
- Developed and customized pharma applications to support the Pharma business team, including medical affairs, drug safety, customer service, facility, and HR.
- Supporting Clinical and Regulatory users managing regulatory binders, submissions, and electronic Trial Master Files (eTMFs).
- Configured Veeva Vault by establishing document types, fields, lifecycles, and supporting automation through workflows and notification management.
- Databases and applications migrations, analysis data between applications, databases and file systems/servers.
- Setting up Stem lab (Placenta and Umbilical cord) Stem Cell banking count processes, maintenance, patches, upgrade with CRM systems.
- 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.
- 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.
Lead
Celgene Cellular Therapeutics/Stem Cell Banking
NJ
05.2006 - 02.2011
- Oversaw deployment and management of Abbott lab medical devices, establishing count processes and managing maintenance, patches, and upgrades for Stem lab (placenta and umbilical cord) stem cell banking.
- Created and executed IQ/QO/PQ/SRS/URS and validation delivers.
- Worked with Abott device vendors, lab integration, Stem Lab application vendors for installation and maintenance and integration.
- Managed website development, design, updates, and support, enhancing user experience and accessibility.
- Collaborated with multiple departments to upgrade sites and integrate other applications to optimize efficiency.
- Ensured compliance with all CCT standards HIPAA, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements.
- Created and maintained regulatory file structures using SharePoint and content management systems, ensuring compliance and efficient data retrieval.
- Http://www.LifebankUSA.com
Consultant
Celgene
NJ
02.2005 - 04.2006
- Managed design and deployment of order management system (COMS_OP), reports system (CRS), integrated finance business codes in C4 system, and implemented software source control and Req-Pro systems.
- Provided technical support and collaborated with finance, customer care, and Sharp Track project teams using MS Project to facilitate project deliverables.
- Maintained compliance with all CCT standards including 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
IndiaSkills
- Project Management
- Program Management
- Product Management
- Project Planning
- Risk Management
- Process Optimization
- Agile
- Scrum
- SDLC
- Cloud Computing
- AWS
- Cloud-Migration
- API
- Digital Transformation
- Data Management
- Big Data Tools
- Python
- Java
- SQL
- Oracle
- PL/SQL
- HTML
- XML
- C
- J2EE
- PHP
- Unix
- FTP & SFTP
- Machine Learning
- Deep Learning
- NLP
- AI
- Gen-AI
- Computer Vision
- IoT
- SAS
- R
- Visio
- Lucid
- Smart sheet
- Office 365
- PowerPoint
- ServiceNow
- ITSM reporting
- Jira
- Subversion
- Veeva
- Salesforce
- Medidata RAVE
- InForm
- Central Designer & Coding
- Pinnacle 21
- RBM
- IRT
- CTMS Clinical Product Study
- QMS
- EQMS
- LIMS
- Track-wise
- Parexel
- IDMP
- MODA
- DTP
- Concerto
- HP ALM
- Reference Manager
- Blueprint
- Matrix
- Pro
- C
- SQL Loader
- Oracle Database
- Forms
- Reports
- EHS Facilities & Chemical Tracking System
- LAB systems
- Clinical & Safety Data ware systems
- Rees
- CTD
- ECTD
- Pace
- EHS Facilities & Chemical Tracking System
- LAB systems
- Data Management
- SharePoint
- Track-wise
- CTD
- ECTD
- Parexel
- Rees
- Clinical & Safety Data ware systems
Certification
- CSM (Certified Scrum Master)
- CSPO (Certified Scrum Product Owner)
- A-CSPO (Advance Certified Scrum Product Owner)
- PMI-AI Prompt Engineering
Reporting Tools
- Qlik
- Tableau
- Teradata
- SAS BI
- Oracle BI
- MicroStrategy
Timeline
PM
Apellis
01.2023 - 12.2025
Sr PM
Eisai
07.2020 - 12.2022
Lead
HCL
01.2020 - 06.2020
Lead
Intercept
10.2018 - 06.2019
Lead/Sr System Analyst
Celgene
03.2011 - 08.2018
Lead
Celgene Cellular Therapeutics/Stem Cell Banking
05.2006 - 02.2011
Consultant
Celgene
02.2005 - 04.2006
Bachelor - Computer Science Engineering
Madras University