Principal Solution Architect, Clinical Data Analytics & Technology

About the role

The Principal Solution Architect will lead the configuration and delivery of a Central Monitoring platform for clinical studies, partnering with cross‑functional teams to implement risk‑based analytics. This senior position drives automation, AI, and advanced statistical approaches to improve risk detection across a global portfolio.

Key responsibilities

• Configure and validate Central Monitoring platforms, including analytics modules, dashboards and reporting solutions.
• Design, maintain and operationalise Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) and statistical monitoring models.
• Deliver end‑to‑end platform setup, user acceptance testing, go‑live activities and ongoing study support.
• Collaborate with Clinical, Data Management, Biostatistics and Technology teams to define analytics strategies and resolve complex data integration, transformation and visualisation issues.
• Advance automation, AI and machine‑learning solutions to enhance risk‑signal generation and reduce false positives.
• Provide technical guidance, training and knowledge sharing to team members and manage relationships with vendors and key stakeholders.

Required profile

• 12‑14+ years of experience in pharmaceutical development, clinical research, data analytics or healthcare technology.
• Proven track record delivering risk‑based quality management and central monitoring solutions across clinical trial portfolios.
• Strong knowledge of ICH E6(R3) risk‑based monitoring principles and clinical trial quality management.
• Excellent leadership, communication and stakeholder‑management skills in a global matrix environment.

Required skills

• SAS, SQL, R, Python for data manipulation, analytics and automation.
• Experience with AI, machine learning and advanced statistical monitoring techniques.
• Hands‑on expertise in configuring central monitoring platforms, dashboards and reporting tools.
• Understanding of clinical data sources such as EDC, CTMS, IRT/IWRS and laboratory systems.