Harivenkatesh Radhakrishnan

http://linkedin.com/in/harivenkatesh-radhakrishnan-2071321/

ad3pl4@r.postjobfree.com

Cell: 732-***-**** Work Status: Green card holder

Professional Experience

Software Development Life Cycle (SDLC) Scrum Agile Waterfall methodology

Apetan (Contractor) Jan 2023 – Dec 2023

SAS: Document the Service now and SAS applications business rule, support process, work flow management process, build process flow diagrams, End-to-end system interface process, vendor management process, build power point 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 vendor, build resolutions, test, validate, document and deliver into production.

Eisai Pharma, Inc. (Contractor) Jul 2020 – Dec 2022

Oncology: Project Plan, scope, design, resource scheduling, cost management, requirements, test cases, integrate, validate, deploy management and documentation management for multiple application. Worked with the 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/Jira/QMS/CTMS/AWS: Upgrade and delivered 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 application.

HCL (Intercept Contractor) Oct 2018 – Jun 2019

HR & Facilities: Provide IT solution 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 Service Now 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. – Summit, NJ (http://www.celgene.com)

FTE March 2011 – Aug 2018

Development / Data Analytic - Design, Develop & customized pharma applications to custom needed to support the Pharma business team like Medical affair, Drug safety, Customer Service, Facility, HR and other department. 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 was migrated to the Salesforce CRM includes 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.

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).

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, StemLab, Solomon, and website site deployment.

Celgene Cellular Therapeutics CCT (LifebankUSA) – Cedar Knolls, NJ (http://www.LifebankUSA.com)

Contractor/FTE May 2006 – February 2011

Website Management – Developed, design, updates, and support of company website. Collaborated with multiple departments to upgrade site 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. – Summit, NJ (http://www.celgene.com)

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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