David Mccarthy Email & Phone Number

United States

Undertaking short-term engagements to help companies interested in adopting an Agile/PMO structure. Review existing project frameworks and document recommendations to better align with current best practices. Present findings to executive team for buy-in.- Perform Agile assessment, providing feedback and coaching to individuals to better align with current.

Kennesaw, GA, US

• Led strategic planning and execution of Technical Portfolio.
• Provided project governance and budgeting oversight through all stages of product development, resulting in consistent, on-time, on-budget delivery.
• Managed a mixed team of 50 independent contractors and full-time employees, providing feedback on performance and guidance toward growth opportunities in their careers.
• Oversaw portfolio with a budget exceeding $15 million.
• Led Business Development and Product Management teams in creating detailed roadmaps and schedules, accurately planning and predicting 100% of product delivery dates over a 12-month period.
• I headed a cross-functional team, ensuring that all activities necessary for a release occurred and were aligned with target dates.

Kennesaw, GA, US

• Formed and led the Technical Program Management Office, overseeing a global, cross-functional team responsible for successfully delivering all initiatives.
• Executed Agile Transformation for the entire Product Development group of more than 60 team members globally located on Agile (SAFe/Scrum) best practices, reducing meeting time by 75%.
• Orchestrated the on-time, on-budget delivery of more than 250 SaaS, on-prem, and mobile (Android & iOS) software releases, supporting eight product lines and five teams across multiple release trains.
• Project Manager for implementation and deployment of both Salesforce and NetSuite solutions.
• Developed a self-serve portal providing dashboards to stakeholders with current project status, KPI metrics, and resource allocation.
• Coordinated bi-weekly meetings with fellow department heads, C-level executives, and other stakeholders to provide status on current efforts and discuss upcoming strategic initiatives and opportunities.

Kennesaw, GA, US

• Streamlined project management methodologies and communications in Product Development, creating a unified voice and eliminating potential confusion.
• Established Project/Program Governance to ensure the right people were working on the project, communications went to appropriate stakeholders, and all milestones/deliverables were achieved on time.
• Managed all development efforts by providing oversight and guidance to Software Development, Technical Documentation, and Product Services teams.
• Oversaw product team in all phases of product development operations—including customer engagement, project chartering, requirements gathering, roadmap creation, and cross-functional go-to-market activities.
• Member of a committee tasked with identifying new R&D initiatives to address strategic product gap
• Day-to-day management of the development team.

Princeton, New Jersey, US

• Led teams through technical and functional requirements gathering, project scoping, roadmap creation, and software development and release.
• Identified risks, challenges, and issues; communicated concerns and solution recommendations to leadership to keep deliverables on track.
• Educated users on system functionalities and delivered release-specific training to technical trainers and stakeholders.
• Met with customers to better understand needs and develop product plans to meet these goals.
• Oversaw roadmap of company ERP, IRT, CTMS, QMS, TMF, LMS, and Clinical LIMS systems.
• Worked with stakeholders to redefine and improve existing SDLC practices, reducing paperwork by 30%.

Princeton, New Jersey, US

• Oversaw CRM, ERP, and IRT systems, steering projects from initiation to completion in line with requirements and business goals with 100% on-time delivery of projects.
• Led development and ahead-of-schedule deployment of five applications representing all aspects of the organization's workflow, including two enterprise systems.
• Oversaw rollout of ServiceNow enterprise software for managing IS/IT workflows.
• Ensure projects were executed following Project Governance standards established by the Technical PMO.
• Drafted project plans comprising all applicable steps in the SDLC process.
• Generated technical documentation covering user and functional requirements, Validation Test scripts, Application User guides, and other materials as needed.

Princeton, New Jersey, US

• Provided quality oversight of 150+ clinical trial studies through all phases.
• Advised project teams on GCP/ICH regulatory guidelines/requirements.
• Performed internal audits on Validation Services and Information Systems teams.
• Authored quality documents, including SOPs, work instructions, study charters, quality assurance plans, and compliance reports. Co-authored quality manual documenting internal audit processes.
• Response Manager for the company’s first FDA inspection

Princeton, New Jersey, US

• The primary point of contact to 100+ international sites in advancing more than 14 clinical studies.
• Monitored project for adherence to regulatory requirements.
• Worked with vendors to ensure materials were provided to clinical sites to meet specific protocol needs.
• Created and quality-checked source documents to collect subject results/assessments for physician readers.
• Quality-checked clinical response outcomes against reading criteria and paradigm.
• Ensured data met defined data transfer specifications agreed upon with the sponsor.

• Provided global project management and staff augmentation for Pharmaceutical & Tech companies.
• Handled Project stages to include Initiation (create proposals and charters, team building/training) Planning, (identify milestones, establish timelines, kickoff), Execution (track progress, establish change management.
• Helped companies determine best practices through review and analysis of internal documentation and procedures
• Specialized in Systems Integration, Product Development, and Manufacturing line retrofitting/validation.
• Generated timelines/milestones and provided budget forecasting designed to meet project goals, while maintaining project scope
• Provided onsite support and conflict resolution

• MedPrompt Solutions, Buckingham, PAServiced Pharmacies, Medical Centers, & Pharmaceutical Industry with Medical Compliance Systems.
• Resolved discrepancies between purchase orders, receiving orders, and invoices
• Handled payroll hours, inventory, and bank deposits
• Provided customer assistance for business, focused on troubleshooting technical issues clients experienced with the product line
• Worked with clients in the Pharmaceutical Industry by assisting with medical compliance during drug trials

Parsippany, NJ, US