Clinical Applications SME for Digital Technology (DT) Clinical Analytics

This is a remote position.

The consultant will join the Clinical Development domain, working in close collaboration with stakeholders from Digital Technology (IT), Clinical Development teams, and external vendors.

The role focuses on implementing, maintaining, and ensuring compliance of technology solutions used in Clinical Analytics, within a highly regulated (GxP) pharmaceutical environment.

The position combines technical application management and project management responsibilities, within a complex and cross-functional organization. 

Typical Day

• Managing and supporting clinical applications (GxP and non-GxP systems)
  
• Maintaining and operating clinical data analysis platforms (including R Shiny apps and dashboards)
  
• Handling system updates, changes, and releases
  
• Supporting validation activities with IT Compliance and QA teams
  
• Managing user access and incidents
  
• Coordinating testing, training, and acceptance activities
  
• Leading or contributing to DT projects (planning, reporting, communication)
  
• Collaborating daily with cross-functional stakeholders and external vendors
  

Requirements

Years of Experience

• Proven experience in IT and project management
  
• Strong experience in clinical development / Pharma IT environments (senior-level profile expected)
  

Must Have

• Strong relevant professional background (key selection criteria from manager)
  
• Experience in GxP environments and regulatory standards (GAMP5, V-model, 21 CFR Part 11, Data Integrity)
  
• Experience in clinical development systems / Health IT
  
• Solid project management experience (including PMO activities)
  
• Ability to work in complex, cross-functional, and matrix organizations
  
• Fluent English
  

Nice to Have

• Experience with R Shiny applications and frameworks
  
• Experience with Power BI dashboards
  
• Knowledge of Agile / SCRUM methodologies
  
• Additional languages (French or Dutch) are a plus but not required
  

Language Requirements

• English: Mandatory (working language)
  
• French/Dutch: Not required (nice to have only)
  

Ideal Candidate

• Strong mix of technical expertise and project leadership
  
• Hands-on experience with clinical analytics tools and platforms
  
• Autonomous, proactive, and solution-oriented mindset
  
• Able to work effectively in a fast-paced and international environment
  
• Strong communication and stakeholder management skills