Remote Clinical Applications SME: Lead GxP & Analytics

MSI Pharma; United States; Remote; USD 137,017 - 205,525; Part time

Job summary

MSI Pharma seeks an experienced Clinical Applications SME to support Clinical Analytics technology solutions within a highly regulated clinical development environment.

This hands-on role blends clinical application management, compliance oversight, and project leadership, working with Digital Technology, Clinical Development, QA/Compliance, and external vendors to ensure platforms remain compliant and fit-for-purpose.

Qualifications

• Experience in pharmaceutical or clinical development environments.
• Strong understanding of GxP-regulated systems and validation processes.
• Proven project management and PMO experience.
• Ability to work across complex, cross-functional, matrix organisations.
• Fluent English communication skills.
• Eligible to work remotely within the EU timezone.

Responsibilities

• Support Clinical Analytics technology solutions in a highly regulated clinical development environment.
• Hands-on clinical applications management, compliance oversight, and project leadership.
• Collaborate with Digital Technology teams, Clinical Development stakeholders, QA/Compliance functions, and external vendors to keep critical platforms compliant and fit-for-purpose.

Skills

GxP Compliance & CSV

GAMP5, V-Model, 21 CFR Part 11 & Data 

Tools

R Shiny Applications

Power BI Dashboards

Job description

MSI Pharma seeks an experienced Clinical Applications SME to support Clinical Analytics technology solutions within a highly regulated clinical development environment.

This hands-on role blends clinical application management, compliance oversight, and project leadership, working with Digital Technology, Clinical Development, QA/Compliance, and external vendors to ensure platforms remain compliant and fit-for-purpose.