Paul Harrison Email & Phone Number

Limerick, Ie

Limerick, County Limerick, Ireland

💠Led the overall Clinical Trial CRO/Sponsor SaaS applications software delivery teams within Advarra with $5M+ annual budget and a team of 40, overseeing the development and implementation of the Longboat and new IRB Platforms.💠Implemented significant functional enhancement and integration of the Longboat platform with existing Advarra services resulting in a 150% increase in Longboat annual revenue post-acquisition by Advarra. 💠Directed multifunction globally based agile teams across all stages of software development, including requirements, design, development, testing, validation, and production support.💠Successfully initiated the development of a new IRB Platform, a critical application supporting Advarra's IRB review business.💠Management and communication of product requirements, design specifications, and validation activities to all stakeholders involved in the software development process. 💠Supported product validation and client audit activities, ensuring implementation and visibility of compliance with regulatory standards and industry best practices.

Limerick & Dublin, Ireland

💠Launched Longboat platform from initial concept to activation of initial customers within 12 months, through adoption by leading global pharmaceutical companies, ultimately leading to the acquisition of Longboat by Advarra in 2020 for a multimillion-dollar sum.💠Led successful design and delivery of client specific customised solution managed via US on-site and remote meetings incrementally over 24-month time period, resulting in approx. $2M of additional revenue per annum.💠Headed delivery of Longboat platform, forming three fully resourced development teams in an agile software development environment.💠Acted as product owner, devising product solutions and defining software application requirements, facilitating effective development, testing, validation, and product delivery. 💠Engaged with customers and internal stakeholders to gather feedback, validate product concepts, and iterate on product features💠Formulated & implemented SDLC & validation process ensuring adherence to clinical trial industry standards for the development, testing, and validation of software applications.💠Supported & guided all client audits on platform for FDA & EU regulatory compliance to ensure successful and continued client engagement. 💠Led and managed a team of manual and automated test engineers. 💠Established and automated test framework, supporting continuous software delivery.

Limerick, Ireland

💠 Collaborated with internal and external clients devising product solutions, system requirements & user stories. 💠 Managed & created product and sprint backlogs to drive timely delivery of project milestones and optimal utilisation of resources.💠 Ensure adherence to 21 CFR Part 11 regulatory standards for the development, testing, and validation of software applications.

Ireland

💠Implemented a comprehensive software development life cycle (SDLC) process, ensuring adherence to 21 CFR Part 11 standards for the development, testing, and validation of software applications.💠Led and managed a team of manual and automated testers in an agile SCRUM-based software development environment, providing guidance and support ensuring high-quality deliverables.💠Collaborated with internal and external clients as a product owner, devising product solutions, creating product backlogs, and sprint backlogs to drive timely delivery of project milestones and optimal utilisation of resources.💠Defined software application requirements with clarity and accuracy, facilitating effective development, testing, and validation processes.

Ireland

💠Defined and implemented a comprehensive software development life cycle (SDLC) process, ensuring adherence to 21 CFR Part 11 standards for the development, testing, and validation of software applications.💠Effectively managed the workload breakdown of SCRUM teams, ensuring efficient allocation of resources and timely delivery of project milestones.💠Oversaw the documentation of software application requirements, ensuring clarity and accuracy for effective development, testing & validation.💠Key contributor to enterprise wide adoption of Firecrest platform for customised use by world's largest Pharma client to resolve their critical regulatory compliance issues.💠Played a significant role in the development and delivery of the Firecrest Site Portal product/application, contributing to the overall acquisition of Firecrest by ICON in 2013 for a multimillion-dollar sum.

Contracting to United Healthcare

Limerick

Contracting to United Healthcare

Limerick

Accreditation, Professional Scrum Master I - Psm I (Scrum.Org)

Pmp, Pmp - Project Management Professional (Project Management Institute (Pmi)

Accreditation, Software Testing Of Computerized Systems In Eu & Fda Regulated Environments

Associate'S Degree, Computer Programming & Information Technology