William O'Keefe Email & Phone Number

Philadelphia, PA, US

• Responsible for product roadmaps and feature development for RTSM (IRT) and RBQM products
• Led multiple scrum teams to deliver high quality releases on time and within budget
• Collaborated cross-functionally to ensure market readiness and drive new sales
• Creation of wireframes to communicate ideas to internal and external stakeholders
• Responsible for data integrations between RTSM and EDC systems
• Responsible for SDTM data warehouse design and integration

• Defined data platform roadmap, shifting analytics to cloud solution (Azure).
• Led process standardization effort, introduced Agile CRISP-DM methodology.
• Vendor selection, technical delivery and presenting status updated to Board of Directors
• Tools: R & Python, Power BI, HealtheAnalytics/EDW, Azure Data Warehouse

• Responsible for oversight of clinical trial data from award through study closure
• Gather, prioritize, and manage reporting requirements and supporting documentation including formal communication and presentations for business stakeholders and leadership
• Functional oversight of Clinical Data Coordinators to ensure that comprehensive data reviews take place and issues are appropriately escalated
• Provided mentoring on Oracle SQL for a quickly growing team
• Leverage data from multiple sources, such as EDC (Rave & InForm), IRT and CTMS systems to provide high quality analytic products in JReview and Tableau - Tools: JReview, Tableau, Postgres SQL

Lansdale, PA

• Responsible for internal data platform roadmap.
• Decision support for senior management, providing impactful analysis and presentations.
• Utilized trial registry API data, leading to a substantial shift in Business Development strategy.
• Automation of project assignments, cut down on resourcing and administrative staff required.
• Utilized Salesforce Service Cloud to set and monitor support KPIs and allocate resources.
• SQL Server: SSIS / SSAS / ML Services (Python / R)

Lansdale, PA

• Led 8-12 QA analysts and automation engineers, helping many to go on to leadership positions.
• Owned automation roadmap, improving system quality and lowering delivery costs.
• Led department process improvement efforts, utilizing Six Sigma methodology.
• HP Quality Center

Yardley, PA

• Translated trial protocols into RTSM (IRT) business requirements for seamless execution.
• Defined UAT requirements and conducted testing to ensure top-notch quality.
• Acted as the primary liaison between customers and internal teams for effective communication.
• Managed worldwide clinical trials as the Clinical Supplies Manager.

• Ensuring RTSM (IRT) & ePRO systems met specifications.
• Testing drug supply forecasting algorithms and associated reports.
• Improving processes and drafting departmental working instructions & SOPs.
• Reviewing the work of peers for quality and compliance.

• Hardware & Software installation
• Security Auditing
• Technical Support

Master Of Science - Ms, Data Science

Bachelors, Computer Science