Clinical Planning & Feasibility Assessment System Owner

Role Summary

Clinical Planning & Feasibility Assessment System Owner is responsible for the leadership, lifecycle management and continuous improvement of Clinical Systems: Clinical Planning in Planisware and Site Feasibility Assessment, a next generation, AI-driven solution. The role collaborates with vendors, IT, process owners, BPMO, and stakeholders to ensure end-to-end delivery of clinical studies, applying continuous improvement methods and ensuring compliance with ICH/GxP.

Responsibilities

• Accountable for design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated systems
• Lifecycle management of all procedural or system documents and ensuring compliance with industry regulations and policies
• Plan and prioritize product feature backlog and development for the product
• Define system vision, road-map and growth opportunities
• Research and analyse business context, users, and roadmap for the assigned system
• Lead and provide direction to service delivery teams within the area
• Engage and influence internal and external stakeholders to drive strategy and improvement
• Ensure customer requirements are understood, evaluated, prioritized and addressed
• Participate in Operational Governance Teams relevant to the area
• Monitor system performance, define and track KPIs, and implement improvement plans
• Support audit and regulatory inspection planning and conduct
• Understand study team needs and provide guidance to remove barriers and identify improvement opportunities
• Provide guidance in planning and delivering system validation activities, including documentation

Qualifications

• Required: Bachelor of Science in life science or computer science, or equivalent
• Required: 5 years of relevant experience
• Required: Understanding of clinical site selection and feasibility assessment
• Required: Experience with Planisware software
• Required: High level of business process, technology and Clinical Study information knowledge
• Required: Extensive experience with computerized systems in a regulated environment (GxP)
• Required: Experience working with external partners delivering mutual benefit
• Required: Proven ability to deliver on time, cost and quality
• Required: Excellent written and verbal communication skills

Desirable

• Experience in tech industry
• Experience with Lean Six Sigma or standard process improvement methodologies
• Knowledge of ICH/GCP
• AGILE certification (e.g., SAFe)
• Quality Systems and Quality Management knowledge
• Project Management certification
• Project Management software experience (e.g., Jira)
• Service Management experience
• Experience with Artificial Intelligence implementation