Location: Remote (EU only)
Engagement Status: Consulting Opportunity for 1 year
Overview
Our client, a global pharmaceutical company, is seeking an experienced Clinical Applications SME to support Clinical Analytics technology solutions within a highly regulated clinical development environment. This is a hands-on role combining clinical application management, compliance oversight, and project leadership. You’ll work closely with Digital Technology teams, Clinical Development stakeholders, QA/Compliance functions, and external vendors to ensure critical clinical analytics platforms remain compliant, operational, and fit for purpose.
Requirements
- Experience working within 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 time zone
Hard Skills
- GxP Compliance & Computer System Validation (CSV)
- GAMP5, V-Model, 21 CFR Part 11 & Data Integrity
- Clinical Systems & Health IT Applications
- Application Lifecycle Management
- User Access & Incident Management
- Testing, UAT & Release Management
- Project Management & PMO
- R Shiny Applications
- Power BI Dashboards
- Agile / Scrum Methodologies
Soft Skills
- Stakeholder Management
- Communication & Collaboration
- Problem Solving
- Proactive Mindset
- Ability to Work Independently
- Vendor Management
- Adaptability in Fast-Paced Environments
Qualifications
- Relevant experience in Clinical Technology, Clinical Systems, Health IT, or Digital Transformation
- Experience supporting regulated applications within the pharmaceutical industry
- Project Management certification beneficial but not essential
Job Type: Contract
Job Location: Europe
Salary: Competitive