Veeva Vault RIM and Clinical
Tim Smith
Medford,MA
Summary
- Experienced consultant with 15+ years in life sciences, specializing in business analysis, agile productoriented delivery (POD), and process improvement across clinical and regulatory functions. Proven expertise in requirements gathering, user stories, and process modeling to deliver Veeva Vault RIM and Clinical (CTMS, eTMF) solutions, achieving a 25% improvement in operational efficiency.
- Demonstrated ability to work with senior leadership and collaborate with the global, crossfunctional business and technology teams to drive meeting outcomes.
- Proven experience with translating complex business requirements into solutions, workflows and supporting full implementation using agile frameworks, achieving 95% on-time delivery.
- Adept at leveraging AI tools and motivating teams to drive deliverables with business objectives to drive a 25% return on investment and GxP compliance.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Sr. Manager, Regulatory Affairs
ICON Plc
03.2021 - 08.2024
- Company Overview: PRA Health Sciences
- Spearheaded in-depth business process analyses to optimize workflows for Veeva Vault RIM and Clinical platforms, improving submission efficiency by 30%.
- Organized stakeholder meetings to gather and prioritize requirements for Regulatory platform, created epics, refined user stories, 20% faster sprint completions, and 15% faster time-to-market
- Developed business and functional requirements to implement multi-pass reporting solutions in Veeva Vault, enabling real-time insights for submissions metrics, improving business operations by 20%
- Created and managed comprehensive backlogs, reducing rework by 15%, and enabling cross-functional collaboration through detailed documentation
- Coordinated with stakeholders to integrate AI-enhanced features into Veeva Vault applications and Power BI dashboards, enabling clinical and regulatory document turnaround time by 25%
- PRA Health Sciences
Regulatory Systems Manager
ICON Plc
01.2020 - 03.2021
- Company Overview: PRA Health Sciences
- Oversaw project to migrate GxP documents and metadata, supporting clinical and regulatory operations
- Provided consistent support for regulatory systems access and change management, achieving a 20% increase in operational efficiency
- Organized workshops to convert user requirements into functional specifications for the regulatory publishing and submission system, resulting in a 30% boost in user satisfaction
- PRA Health Sciences
Sr. Consultant Advisory-Life Sciences
Ernst & Young LLP
03.2016 - 01.2020
- Company Overview: EY
- Advised sponsors in implementing the Agile-based POD for 7+ GxP-compliant clinical, lab and regulatory systems, contributing to a positive return on investment of 20%, adhering to CFR Part 11
- Developed user stories, product backlog, risk assessments, test scripts, and traceability matrices for clinical and lab management systems, leading change management with 95% user satisfaction
- Oversaw Agile ceremonies, including sprint planning and retrospectives, enabling a 30% faster delivery of the Minimum Viable Product (MVP) and sprint readiness at global R&D sites
- EY
Consultant-Regulatory Affairs & Compliance
Cognizant Business Consulting
07.2013 - 03.2016
- Company Overview: Life Sciences
- Led stakeholder workshops to gather requirements, prioritize features, and track project milestones, delivering 95% of projects on time and within budget
- Streamlined workflows and data flows for clinical trials, increasing process efficiency by 30% and reducing trial start-up times by 20%
- Represented business working with development and QA teams to address bottlenecks, improving overall efficiency and ensuring that subsequent sprints delivered on time, with 15% improvements
- Life Sciences
Business Analyst- Regulatory Affairs & Compliance
Cognizant Business Consulting
07.2008 - 06.2013
- Company Overview: Life Sciences
- Delivered Global Clinical Site Operations System integrating with eTMF and CTMS, improving trial efficiency by 15%, enabling real-time inspection readiness
- Developed and prioritized user stories for eTMF enhancements, improving collaboration across cross-functional teams and meeting 100% of sprint objectives
- Produced epics, user stories, and qualification criteria for eTMF and CTMS systems, ensuring alignment with business needs, resulting in 95% defect-free deployment rate
- Life Sciences
Education
Master of Business Administration (MBA) -
University of Massachusetts Amherst, Isenberg School of Management
03.2025
Machine Learning: From Data to Decisions -
Massachusetts Institute of Technology (MIT)
Cambridge, MA11.2019
MBA - Pharmaceutical Management
National Institute of Pharmaceutical Education And Research (NIPER)
Mohali, India07.2008
Bachelor of Pharmacy (B.Pharm.) - undefined
Ganpat University
05.2008
Skills
- Agile Methodology
- Business Analytics
- User Stories Writing
- Product Backlog Management
- Business Process Improvement
- Project Management
- Computer System Assurance
- Communication and Reporting
- Cross-Functional Coordination
- Change Management
- Clinical Trial Management-GCP
- Veeva Vault-RIM
- CTMS
- ETMF
- Data Visualization-PowerBI
- MS Office
- Visio
- Jira
- Miro
- Artificial Intelligence (GenAI)
Accomplishments
- Collaborated with team of [Number] in the development of [Project name].
- Achieved [Result] by introducing [Software] for [Type] tasks.
- Achieved [Result] through effectively helping with [Task].
Certification
- Regulatory Affairs Certification (RAC)
- Project Management Professional (PMP)
Publications
Setting up a Quality Management System (QMS) in Global Medical Device Regulatory Strategy, RAPS, Second Edition, p59-92
Affiliations
- Project Managment Institute
Software
QMS
MS Office, Visio, Project
Jira and Miro
Data Visualization- PowerBI
Timeline
Sr. Manager, Regulatory Affairs
ICON Plc
03.2021 - 08.2024
Regulatory Systems Manager
ICON Plc
01.2020 - 03.2021
Sr. Consultant Advisory-Life Sciences
Ernst & Young LLP
03.2016 - 01.2020
Consultant-Regulatory Affairs & Compliance
Cognizant Business Consulting
07.2013 - 03.2016
Business Analyst- Regulatory Affairs & Compliance
Cognizant Business Consulting
07.2008 - 06.2013
Bachelor of Pharmacy (B.Pharm.) - undefined
Ganpat University
Master of Business Administration (MBA) -
University of Massachusetts Amherst, Isenberg School of Management
Machine Learning: From Data to Decisions -
Massachusetts Institute of Technology (MIT)
MBA - Pharmaceutical Management
National Institute of Pharmaceutical Education And Research (NIPER)
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