Business Analyst Product Management

Rinkey Aggarwal

Phone- +1-760-***-****

Email- ************@*****.***

Location- San Diego

Visa- L2 EAD

PROFESSIONAL SUMMARY

An experienced leader with over 17 years’ experience across life science research markets with extensive consulting experience. A results-oriented leader with a data-driven approach, skilled at aligning customer needs with company strengths to deliver effective product solutions. Expertise in orchestrating end-to-end product lifecycles and strategic leadership, from initial planning and stakeholder alignment to seamless execution and post-implementation optimization. Adept at navigating complex regulatory landscapes and ensuring compliance with industry standards.

Skills:

Leadership & Strategy

●Develop successful multi-year product roadmaps through partnership with cross functional teams.

●Ensure profitable, sustainable product portfolios through close collaborations with operations and support teams.

●Spearhead the design and implementation of product features to address customer needs.

●Build strong, business-oriented product management teams.

Tactical & Execution

●Requirements Gathering and Analysis, UI/UX designing Clinical Workflow Optimization, Feature Prioritization, Project Execution

●Manage integration of applications with existing clinical/non-clinical R&D systems

●Quality Assurance and User Acceptance Testing: Oversee or participate in testing phases, ensuring clinical systems meet performance and usability standards.

●Risk Management: Identify potential risks during execution and develop mitigation strategies to avoid disruptions in clinical operations.

●Vendor and Partner Management: Work with third-party vendors for system implementations, upgrades, or integrations to ensure alignment with product goals. Vendor selection, qualification and management

●Change Management: Develop and execute plans to support users through system changes, including training and communication strategies.

●Statistical and quantitative analysis: understanding of statistical concepts, SAS Base, SAS Studio R, Minitab

●Quality Management: Compliance and Regulatory Management, Audit preparedness, Continuous improvement, Deep understanding of industry, best practices, Training, CAPA, SOP

Technologies & Applications:

●Clinical and other systems (COTS and non-COTS): Veeva platform (CRM, QMS, EDC, CBD, RIMS, Quality Docs, PromoMats, CTMS, Medidata Rave, Elluminate, InteliNotion, Salesforce CRM, CLM, Digital Protocol Library

Project Management and other tools

●JIRA, qTest, Trello, Monday.com, Smartsheet, Confluence, Airtable, Balsamiq, Visio, Trello, Lucid Chart

Product Management Methodologies

●Agile (Scrum, Kanban, SAFe), Lean, Waterfall, User-centric design, Value proposition canvas, Prioritization framework

Reports

●Power BI, Tableau

Regulatory & Compliance

●21 CFR Part 11, 21 CFR Part 312, ICH E6 (R2) Guidelines, 21 CFR Part 58-GLP, IEC 62304,

SENIOR BUSINESS ANALYST CONSULTANT (DATA AND KNOWLEDGE MANAGEMENT) — Vertex Pharmaceutical (R&D) — US

November 2024 - Present

●Led the analysis of program ontology data to refine and enhance the early discovery phase ontology. This effort was driven by the needs of approved projects that required more precise ontology-supported terminology and data models.

●Led business analysis and developed comprehensive analytical frameworks through a multifaceted approach integrating strategic documents and existing data ontologies. Insights extracted from detailed data across various R&D applications utilized during drug discovery phases.

PRODUCT MANAGER /BUSINESS ANALYST— Takeda Pharmaceutical — US

October 2022 - April 2024

●Led the development of a Clinical Data Lake on Amazon S3, overseeing cross-functional agile teams through all stages of the product lifecycle.

●Successfully deployed robust system architecture for compliant data ingestion, transformation, and integration using AWS technologies (S3, Glue, Step Functions).

●Deployed data pipeline for ingestion of structured raw clinical data to be leveraged by end uses for SDTM creation and reporting uses, Data pipelines- RBQM, Elluminate to and from Clinical data lake, Veeva CDMS, Argus and Empatica. Downstream data pipeline to Veeva CTMS.

●Collaborated in multiple product strategies including Elluminate, Intelinotion, Veeva platform (CTMS, QMS and EDC study builder). Utilized automated workflows in Veeva Vault to expedite quality document approvals, decreasing average review.

Responsibilities:

●Develop and execute comprehensive strategic project plans aligning customer requirements with company’s goals.

●Lead GxP quality activities, including IQ/OQ/PQ, URS, validation plans, configuration specifications, release plan, SOPs, CAPA, WIs, training materials etc.

●Lead internal regulatory compliance audit, identify compliance gaps, create mitigation plans, and promptly notifying Quality Management of suspected, significant data integrity breaches according to SOP’s and Quality Incident Management protocols

●Extensive contribution towards Veeva implementation and integration planning strategy for the organization.

PRODUCT MANAGER/BUSINESS ANALYST— Genentech — US

February 2022 - July 2022

●Directed the first deployment of a custom cloud-based product suite for structured content management, improving protocol development lifecycle management within the clinical scientist (early drug discovery and research) community.

●Reviewed the organization and maintenance of trial master file documentation in Veeva Vault eTMF, ensuring all relevant protocols can be extracted and filed accurately to meet regulatory standards.

●Lead Data Science team to leverage indexing and search algorithms including model training using AI/ML, validation and refinement to enable quick and precise extractions of specific protocol content using machine learning models.

●Championed an iterative development approach within Agile sprints, gathering user requirements to defining epics and user stories, allowing for rapid feedback cycles and continuous improvement based on feedback, testing, and evolving industry standards.

Responsibilities:

●Lead the creation of models using content modelling strategy for managing structure content authoring processes which are easily managed, reused, and repurposed.

●Lead Data Science team to leverage indexing and search algorithms including model training, validation and refinement to enable quick and precise extractions of specific protocol content using machine learning models

PRODUCT MANAGER/SENIOR BUSINESS ANALYST — Cognizant Technologies Client MARS (Manufacturing and Supply Chain operations) — UK

September 2020 - August 2021

●Managed Salesforce Lightning platform project to enhance customer support processes and workflow efficiency, achieving significant cost savings and performance improvements.

●Delivered salesforce platform implementation to optimize business operations for providing support across multiple functions, getting insights into customer satisfaction, and tracking customer issues and queries Utilized advanced reporting features resulting 35% increase in efficiency and 1.5 million of cost savings across 4 nations within the first six months of deployment

●Guided client in improving existing business processes, workflows, determine requirements and deliver data-driven recommendations with reports to executives and stakeholders.

Responsibilities:

●Define the product vision and strategy aligned with business goals, budget schedule and timelines.

●Developed integration strategies with Power BI for enhanced data visualization and decision-making support.

●Establish processes to support management of the entire lifecycle of custom product development, from concept to delivery

PRODUCT DELIVERY MANAGER/LEAD BUSINESS ANALYST — Cognizant Technology Solutions, Client Unit4— UK

October 2019 – August 2020

●Revamped Salesforce CPQ and Sales Cloud solutions to improve quote management and sales processes, integrating productivity tools to boost team efficiency and customer engagement.

●Integration with email and productivity tools such as Microsoft Outlook to allow users to sync emails, calendars, and tasks between Salesforce Sales and other applications, enhancing collaboration and productivity. Implemented automation tools that reduced average ticket response by 10% from 6 hours to 45 mins

●Implemented sales analytics to track sales KPIs to measure the effectiveness of sales strategies and identify activity patterns as well as sales forecasting to predict sales revenue.

Responsibilities:

●Accelerated global technology adoption of Salesforce Sales Cloud and Salesforce CPQ within Unit4 Group, enhanced internal user adoption from 25% to 100%; Sales Support 40% to 100%

●Designed a system to track satisfaction ratings of all customers that improved client retentions by 20%

●Integration with CLM Cogna.

LEAD BUSINESS CONSULTANT — Cognizant Technology Solutions, Client Astellas Pharma ltd — UK

August 2018– September 2019

●Implemented Veeva Vault PromoMats to streamline compliance and digital asset management across multiple divisions, significantly improving document control and approval processes.

●Developed foundational product workflows and software metadata configurations to facilitate the creation, approval, tracking, and distribution of digital assets within the Astellas Veeva Vault PromoMats system

●Collaborated with Digital stakeholders to design, implement, and test features within the Digital Content ecosystem, focusing on Veeva PromoMats and required integrations with Veeva CRM by analyzed data models, standards, and asset management workflows to ensure alignment with project objectives.

●Trained cross-functional teams on using Veeva Vault Quality Docs, increasing adoption rates by 40% and improving document control across departments.

●Provided support for the migration activities of the legacy CTMS system to Veeva CTMS (clinical trial documentations (e.g. data/filed mapping, etc.) and responsible for leading Veeva Vault CTMS changes and implementation alongside Promomats. Including definition and harmonization of L1/L2/L3 business processes for CTMS.

Responsibilities:

●Provide strategic product guidance for a Veeva Vault PromoMats implementation project aimed at enhancing global brand management and compliance across sales, marketing, and regulatory functions

PRODUCT DELIVERY LEAD/LEAD BUSINESS ANALYST— Cognizant Technology Solutions, Client MSD (Merck & Co.) — UK

July 2017 – July 2018

● Led the development and deployment of a Web-based application for diabetes care management, integrating clinical and digital tools to enhance patient care and compliance.

●Successfully deployed in fourteen pilot sites (General practices) within UK to demonstrate how redesigning primary care and robust community partnerships addresses social drivers of health which can help improve the delivery of diabetes care.

●Delivered refreshed customer profile experience, increasing traffic to the website by 55% with more than 10K unique account creations within first 30 days of deployment by successfully executing digital enhancements and cloud adoption to transform user interaction and experience

●Align stakeholders' expectations with continuous project deliverables, stakeholders included Commercials, Marketing, Field Medical Affairs, Clinicians, KOL’s and Regulatory department.

Responsibilities:

●Define the product’s strategic direction, develop and maintain a high-level product roadmap that aligns with business objectives and stakeholder expectations, incorporating regulatory requirements, customer feedback, and market trends.

LEAD BUSINESS ANALYST — Cognizant Technology Solutions, Client Genomics England (100k Cancer and Rare Disease Research) — UK

July 2015 – March 2017

●Orchestrated a genome-sequencing project's data management environment, focusing on clinical data management, sample management, and bioinformatics.

●Expertise in Personas, Patients Journey, User stories, requirements documents, acceptance criteria and DoD's

●Consulting and scoping support to define the roadmap of the research platform analytics, determining specific needs such as business procedures, workflows, evaluating fit for purpose genomics products and roll out strategy

Responsibilities:

●Managed C Suite Stakeholders to create business strategies for future service offerings, models for direct engagements and exploring new market opportunities.

PRODUCT OWNER/ LEAD CLINICAL DATA MANAGER — British American Tobacco — UK

January 2011 - May 2015

●Successfully implemented and managed FDA compliant data analytics environment now known as SAS Life Science Analytics Framework, used GAMP V model to fully validate the bespoke systems integration to comply with 21 CFR part 210 and 11

●Review data management deliverables like DMP, ePRO, eCRF specs, validation specs, study database (EDC) designed by CR ensuring they meet FDA and CDISC requirements for the entry and reporting of clinical data.

Responsibilities:

●Led team of 5 direct reports and mentored over 20 data management colleagues

●R&D Clinical Data Management and Statistics responsibility for sponsored studies

●Manage CRO’s, technology vendors and service providers

●Standardize R&D data using CDISC device standards for tobacco delivery devices produced by BAT

●Implement ELN and LIMS for R&D wide labs, performed CSV in compliance with GLP

OPERATIONS ANALYST-SUPPLY CHAIN PLANNING — FLYING TRADE LIMITED, UK April 2010 - December 2010

●Managed product direct deliveries, ensuring processes are appropriate, effective, efficient, and supports service deliveries.

●Maintain quality and integrity of the data by inputting and verifying of data into SAP

Responsibilities:

●SKU and Inventory management

CLINICAL DATA MANAGER/EDC DEVELOPER — Cognizant Technology Solutions, — India January 2008 - January 2009

●Managed and lead the team of RAVE EDC database developers who were responsible for clinical trial study set-up and data migration, ensuring the project documents related to study development are FDA compliant.

CDM SPECIALIST — Accenture – India October 2006 - November 2007

●Worked as an eCDM (RAVE) Specialist for a leading global provider of electronic clinical data capture, management, and reporting solutions

INSILICO RESEARCH SCIENTIST — Jubilant Biosys - India July 2005 - August 2006

●Worked as a Bio target analyst in a potent drug molecule project within the Drug Discovery Department.

Identification of disease pathways and the critical disease genes, pathway crosstalk, comparison of pathways across physiologies, diseases, organisms.

Education

MBA-INTERNATIONAL BUSINESS= University of Wolverhampton- 2010 – UK

MASTER OF SCIENCE (M.S.) IN GENETICS- Bangalore University- 2005 – India

BACHELOR OF SCIENCE (B.S.) IN GENETICS — Bangalore University-2003 – India

Certifications

●BCS Business Analysis Practice Certificate

●Agile Business Analysis Foundation (APMG)

●PMP equivalent- Certified PRINCE2 Project Management methodology, UK

●ICH-GCP training and Certification, CDISC all modules trained, Core member of CDISC Devices terminology group

●Quality Assessments, Computer system validation, GAMP 5, GxP

●Product Management Professional Certificate

●Machine learning Foundations for Product Managers

●Trained on GDPR, HIPAA data privacy regulations

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