Machine Learning Project Management

Harivenkatesh Radhakrishnan

https://www.linkedin.com/in/hari-radha-2071321/

**********************@*****.***

Cell: 732-***-****

CORE KNOWLEDGE & SKILL AREAS: AI, Gen-AI, Machine Learning & Deep Learning, Natural Language Processing (NLP) & Computer Vision, Data Engineering, Cloud Computing & AWS. SDLC Scrum Agile Waterfall methodology Product deliver, Business Support, Analyst & Manage digital IT Pharma Domains.

Software Development Life Cycle (SDLC) Scrum Agile Waterfall methodology

● I’m a proactive self-starter with the ability to independently manage and oversee Financial/Asset/Pharma/Biotech/Healthcare domain IT projects with minimal supervision after the initial knowledge transfer. Experience in software engineering and technical customer-facing roles..

●Requirements Gathering, Ability and effectively gathered, analyzed, and documented business requirements from stakeholders. Process Mapping: Skilled in documenting and analyzing business processes using tools like flowcharts, ServiceNow, Visio. Stakeholder Management: Strong ability to communicate and collaborate with SME, Senior Management & Stakeholders. Problem-Solving: Proficient in identifying business challenges and recommending solutions. Data Analysis: Ability to interpret data, identify trends, and use data-driven insights to make informed decisions. Communication Skills: Excellent verbal and written communication skills for clear documentation and presenting findings. Business Acumen: Understanding of business operations, strategy, and the industry to align solutions with company goals. Requirements Documentation: Proficiency in creating URS, FRS, user stories, and other project documentation like Val Plan, VSR, Test cases, UAT, Traceability Matrix, IQ, OQ, PQ etc. Change Management: Ability to support and guide teams through organizational changes associated with new systems or processes. Testing & Validation: Experience in validating and testing solutions to ensure they meet business requirements by cross reference with URS, FRS, TM, UAT, Test cases, stories etc.

●Project Management: Deep KT with project management methodologies (Agile, Scrum & Waterfall).

Technology Understanding: Knowledge of IT systems, Data, databases, middleware, API’s, Integration, daily, weekly jobs, software tools relevant to any organization. Agile/Scrum Methodology: Experience working in Agile environments and with Scrum teams. Stakeholder Negotiation: Ability to balance competing demands and negotiate compromises between business needs and technical. Risk Management: Ability to identify, assess, and mitigate potential risks in business processes or systems. Document Risk management process, tasks, activities. Soft Skills: Strong interpersonal, collaboration, and active listening skills.

Testing Knowledge: Experience with deep KT UAT (User Acceptance Testing) or other testing methodologies.

Industry-Specific Knowledge: Familiar and detailed KT with the transportation & logistics industry to understand sector-specific challenges. SQL/Database Querying: Ability to write basic and advanceSQL queries for data extraction and analysis. Lead project work group meetings and own regular status communications to stakeholders. Interact with a wide variety of stakeholders including senior business partners. Ensured all project deliverables are managed on time and with high quality.

●Understand and translate complex investment and operational challenges into clear, effective prompts for LLMs. Collaborate with architects and technical leads to integrate data, documents, requirements and leverage user feedback and performance metrics to continuously refine prompt engineering and establish and manage a centralized prompt repository with proper governance and traceability. Develop and deliver training sessions to equip teams with prompt engineering skills. Identify and deploy tools to automate prompt generation and refinement. Run pilot projects in parallel with existing processes to ensure risk-managed innovation. Engage with investment, operations, and AI teams to align technical solutions with business needs. Demonstrated experience in prompt engineering, AI development, or related LLM-based roles. Python development and other scripting experience. Proven ability to translate complex business data, documents and other challenges into technical solutions. Strong understanding of LLMs, prompt optimization, and enterprise integration. (PMI Certified Talking to AI: Prompt Engineering for Project Managers).

●Coordinated and facilitated routines to support delivery, kick-offs, status reviews, stakeholder meetings, change controls, tollgates and management activities. Plan and coordinate delivery and dependencies across multiple teams

●Facilitated dependency management/risk management/impediment removal against deliverables. Promote/facilitate communication and collaboration across organizations to support the deliverable completion and timeline

●Gather/facilitate status updates for the deliverables to stakeholders and leadership pertaining to delivery, risks/issues, and schedule. Ensure that execution is aligned with deliverable requirements by working with stakeholders

●Ensure deliverables comply with Enterprise Change Management standards. Conduct Release Readiness reviews, Milestone Reviews, and Business Go/No-Go reviews. Communicate release details and schedules to the Business as required.

●Project status oversight & report on delays/risks/issues across priorities. Data quality support, such as reviewing reports and partnering with project managers on timely corrections. Portfolio/Program oversight and regular required updates such as tangible business outcomes and metrics

●Quality assurance reviews and audits. End-to-end project management experience including process improvement/re-engineering in the Agile project methodology for both process only and/or technology change efforts

●Passionate project manager who enjoys working on technology projects and being part of a skill group with like-minded agile professionals. Strongly proficient using Microsoft Office - Word, Excel, PowerPoint, Project, Visio, SharePoint, JIRA

●Strong PowerPoint presentation skills and ability to target messaging to different audiences

●Experience with managing a large, complex group of stakeholders and ability to communicate effectively and influence decisions to achieve desired results

●Strong decision-making skills with an assertive and proactive communication style

●Excellent communication skills (verbal, written and presentation) and active listening skills

●Excellent organizational skills and be able to handle multiple tasks to meet extremely compressed deadlines

●Enthusiastic, energetic, determined and positive – especially under pressure, ability to navigate enterprise, research and resource information

●Critical thinker and risk-minded, Experienced supporting and participating in technology change efforts in project manager role. Proficient in data management to include strong data analytic capability, understanding technology and data management. Project management experience with a complete understanding of the key principles and frameworks of Project Management and Process Development.

●Experienced in using tools ServiceNow, ALM, Veeva & Salesforce. Deep knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools. Good knowledge of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of tools like ALM & ServiceNow

●Ability to make decisions that impact on own work and other groups/teams and work under minimal supervision. Demonstrates openness to learning and developing. Takes responsibility for their own development and growth.

●Managed and delivered highly impactful Pharma domain projects. Manage the strategy of technology enabled capabilities.

●Worked on Salesforce Life sciences enabled Clinical patient projects capability to provide insights into the patient's cell/gene therapy.

●Worked with both business partners and IT solution owners in close collaboration with the IT solution owner and business owner, managing the build and launch client’s PM & SDLC process.

●Experience in managing projects using Agile (Scrum), Waterfall, and Hybrid methodologies, ensuring successful delivery through adaptable planning, stakeholder communication, and continuous improvement.

●Experienced in Financials, Banking, Pharma business experience in predictive modeling, analytics, management.

●Intellectual curiosity and passion to learn new things.

●Experienced in practical application of predictive modeling and demonstrated ability to translate technical findings for nontechnical audiences required.

●Excellent communication, project management, and executive presence.

●Skilled in data extraction and summarization from large datasets using SQL and basic statistical analysis using preferred languages (i.e., Python, SQL, R). Flow Diagram drawing, SQL, Visio, excel, power point

●Experienced working with large pharmaceutical data sets (e.g., IQVIA, SHS, MMIT…etc.).

●Demonstrated understanding of omnichannel marketing, especially within the pharmaceutical industry.

●Experienced leading and advising in marketing mix/optimization or other promotional measurement solutions.

●Experienced in IT Compliance and computer systems validation (CSV) in the pharmaceutical industry. Good understanding of Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP methodologies and Agile methodologies. Experienced in implementing validation strategies for various functional business organizations within the pharmaceutical industry in Clinical and Regulatory domain.

Apetan (BA/PM) Jan 2023 – Apr 2023

Experienced requirements gathering, converting as validation deliverables and documents. Supporting systems and technology solutions for the Biostatistics & Data Management domain. Product & Project lead with track record of delivery & maintenance of both products & projects in a fast paced environment. Strong technology project, stakeholder, budget management and collaboration skills. Comprehensive knowledge of Clinician database development including Medidata Rave and 3rd parties. Knowledge of the EDC and ability to discern pro/con analysis of the different Vendors and formulate a future state strategy. Experienced in managing relationships with Medidata and other EDC Vendors and roadmaps to align with goals and objectives. Knowledge of eSource systems and integrating eSource systems. Knowledge of emerging technologies such as Veeva Quality Vault, Python, PySpark, AI, ML, DL, NLP & other software. Document the Service now and SAS applications business rule, support process, workflow management process, build process flow diagrams, End-to-end system interface process, vendor management process, build powerpoint presentations. Derive and document the IT process rules that need to flow from the business end user IT ticket creation, ticket process, assign tickets to vendors, build resolutions, test, validate, document and deliver into production. Document management/document change control, quality management system (QMS) support, technical communications. Experience MS Office Suite, Sales Force, Compliance Quest, and TrackWise.

Eisai (BA/PM) Jul 2020 – Dec 2022

Worked on Financial and marketing technologies Salesforce, MS Project (Microsoft Project), MS Excel, MS SmartSheet. Waterfall/Agile/Scrum methodologies, worked on large projects, worked as a Business Analyst (Strong functional/technical requirement gathering, with a focus on data and integrations), worked on user requirements. Worked on testing coordination. Ability to produce process maps (e.g. functional processes, high level data flows) and demonstrated ability to trace requirements to testing, acceptance criteria, and process flows.

Project Plan, scope, design, resource scheduling, cost management, requirements, test cases, integrate, validate, deploy management and documentation management for multiple applications. Worked with the Financial, Clinical Pharma Architecture, PMO office, ITIL frameworks, SDLC, GAMP5.

Study Migration: Migrated legacy system study data to latest build SAS environment, which includes project plan, resource, data mapping, file transfer, change control, accounts, study partners & sftp setup, UAT, validation deliverables, vendor management, QA/QC tasks. (MS Office 365 / Project )

Technology: SAS M7/Oracle ERP/Jira/Java/QMS/CTMS/AWS: Upgrade and deliver ECCE 1.2, SAS M7, Pace 4.1.2 and Jira platform in-house build software. Project management activity & tasks. MS office 365, Service Now, DocuSign, Jira, Varonis. Proficiency skills are Quality analysis, Applications, infrastructure, data integrity, continuous improvement process (Agile, Scrums, DevOps & waterfall), Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management. Processing sales orders in the SAP and Concur travel expenses processing and reports.

HCL (Merck Contractor) Jan 2020 – Jun 2020

Documentation Management System: Plan, design, requirements, validate, test cases, integrate, deploy the documentation management system for multiple applications.

HCL (Intercept Contractor) Oct 2018 – Jun 2019

●HR & Facilities: Provide IT solutions to the HR depart from hiring till retirement process, which involves design, planning, requirements, develop, configure, test, implementation, deliver onboarding to retirement stages for the HR systems/ technology. Enhance/maintain data quality in the Oracle HCM and Servicenow HR module. 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 Pharma, Inc. (FTE) March 2011 – Aug 2018

●Development / Data Analytic - Design, Develop & customize pharma applications to custom needed to 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.

●Salesforce Migration – The SalesLogix CRM was migrated to the Salesforce CRM including database, forms, reports and interfaces. The migration initiative was handled with vendor, offshore and onsite teams for the Celgene Cellular Therapeutics CCT LifebankUSA / LifebankUSA.com.

CCT (LifebankUSA) Contractor/FTE May 2006 – February 2011

●Website Management – Developed, designed, updated, and supported the company website. Collaborated with multiple departments to upgrade sites and integrate other applications to optimize efficiency.

●IT Systems– Effectively led IT systems administration and support at the facility.

●Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements.

Celgene Inc IT Consultant February 2005 – April 2006

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

●Project Support– Provided technical support for all systems and applications and collaborated with multiple departments, the Sharp distribution vendor, and the Solomon customer care center. Track project tasks and multiple roles and responsible using MS project tool as a project deliverables.

●Compliance – Ensured compliance with all CCT standards, 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 Qualifications

Bachelors in Computer Science Engineering – University of Madras, India

Certificate: CSM (Certified Scrum Master),

CSPO (Certified Scrum Product Owner),

A-CSPO (Advance Certified Scrum Product Owner)

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