ERegulatory
Henil Shah
Senior Manager, Product Management
Katy,TX
Summary
Strategic head of product management with years of experience leading product-market strategy and supporting implementation of innovative products for unique niches. Creative strategic planner with product value and impact assessment prowess. End-to-end product leader successful bringing products from inception to rollout with efficiency and speed.
Overview
10
10
years of professional experience
3
3
Certifications
Work History
Senior Manager, Product Management
DM Clinical Research
03.2023 - Current
- Led end-to-end product management for the development and deployment of clinical research site systems, including clinical trial management systems (CTMS), eConsent, patient stipend, transportation platform.
- Optimized overall product performance through rigorous testing, analysis, and iteration cycles.
- Worked closely with cross-functional teams and vendors & engineering team to ensure timely and accurate delivery of clinical research web and mobile app, adhering to budget and timeline constraints.
- Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
- Acted as a subject matter expert in clinical research vendor and product development, providing guidance and support to project teams and supporting ongoing system enhancements.
- Developed and maintained project documentation, including project charters, project plans, requirement documents, testing plans, and status reports.
- Developed product documentation to communicate upcoming features and products to internal teams.
- Certified Scrum Product Owner
- Led UAT testing and validation efforts to ensure system compliance with user expectations, regulatory requirements, best practices, and internal policies.
- Ensured effective training of end-users and clinical research staff on the use of clinical research site systems.
- Managed post-implementation support and maintenance to ensure continued system functionality and optimization.
- Developed comprehensive product roadmaps, establishing clear goals and timelines for development teams.
Site System Manager
DM Clinical Research
07.2022 - 02.2023
- Responsible for vital systems in clinical research: eSource, eReg, eConsent, EDC, Patient Stipend and Transportation, and CTMS platforms.
- Maintained relationships with biggest stakeholder's sites and sponsors.
- Responsible for migration and integration of sponsor EDC platform to site provided EDC platform.
- Project management including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
- Hands on experience of eSource design and manage team of designers to ensure protocol and eCRF guidelines requirements are met.
- Orchestrated smooth and efficient program development by collaborating cross-functionally across departments.
- Managed multiple strategic projects with numerous sub-projects or workstreams.
- Built teams to address project goals and objectives for multiple projects.
Assistant System Operations Manager
DM Clinical Research
10.2021 - 07.2022
- Developed project plans and managed project scope using methodologies to guide projects from conceptualization to implementation and maintenance.
- Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
- Maintained schedules to meet key milestones at every project phase.
- Reviewed documentation and identified financial discrepancies where applicable.
- Supported operations management, sales and marketing efforts to increase revenue and overall financial health.
- Responsible to audit eSource and EDC platform to ensure financial and data management quality.
ESource Specialist
DM Clinical Research
04.2021 - 10.2021
- Followed all company policies and procedures to deliver quality work.
- Build study in eSource platform during startup phase and any amendments based on protocol, eCRF and lab manual guidelines.
- Attended training programs to deepen professional skillset and assisted in training fellow store associates on existing and new training programs.
- Managed daily eSource creation, finance configuration and system user management to support business needs.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
Research Analyst
Baylor Scott And White Health
03.2019 - 04.2021
- Analyzed statistical data using both modern and traditional methods.
- Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations.
- Supported design and implementation of survey instruments such as telephone questionnaires to obtain study information.
- Interpreted data and made recommendations from findings.
- Demonstrated products to show potential customers benefits and advantages and encourage purchases.
- Studied demographic data to determine optimal targets, competitor offerings and tactics for persuasion.
- Identified and pursued valuable business opportunities to generate new company revenue and improve bottom line profit.
Student Transition Lead
University Of Texas At Dallas
04.2018 - 03.2019
- Managed supplies, processed new orders and maintained inventory organization for team.
- Greeted incoming office visitors, answered questions and directed individuals to office locations.
- Offered quality clerical support to department personnel.
- Completed clerical tasks such as filing, copying and distributing mail.
Customer Service Area Supervisor
Kohl's Department Stores, Inc
07.2014 - 11.2016
- Monitored metrics and developed actionable insights to improve efficiency and performance.
- Created, prepared and delivered reports to various departments.
- Established and updated work schedules to account for changing staff levels and expected workloads.
- Created customer support strategies to increase customer retention.
- Conducted training and mentored team members to promote productivity and commitment to friendly service.
- Motivated employees through special events, incentive programs, and constructive feedback.
Education
Master of Science - Healthcare Administrator
Texas Tech University Health Sciences Center
Lubbock, TX 01.2020 - 2021.12
Bachelor of Science - Healthcare Studies
The University of Texas At Dallas
Richardson, TX 01.2017 - 2019.12
Skills
Stakeholder Management
Certification
PMP - Project Management Professional
Software
CTMS System
Microsoft Power BI
EPIC- EMR system
Azure ADO Board
Hotjar
Trello/Asana
Jira/Confluence
Timeline
Certified Scrum Product Owner
01-2024
Senior Manager, Product Management
DM Clinical Research
03.2023 - Current
Site System Manager
DM Clinical Research
07.2022 - 02.2023
Assistant System Operations Manager
DM Clinical Research
10.2021 - 07.2022
ESource Specialist
DM Clinical Research
04.2021 - 10.2021
Master of Science - Healthcare Administrator
Texas Tech University Health Sciences Center
01.2020 - 2021.12
Research Analyst
Baylor Scott And White Health
03.2019 - 04.2021
Student Transition Lead
University Of Texas At Dallas
04.2018 - 03.2019
Bachelor of Science - Healthcare Studies
The University of Texas At Dallas
01.2017 - 2019.12
Customer Service Area Supervisor
Kohl's Department Stores, Inc
07.2014 - 11.2016
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