Senior Business Analyst

Our client is transforming its fragmented legacy clinical data landscape into a modern, governed Clinical Data Layer (CDL). The objective is to centralize, manage, govern, and secure clinical data in compliance with regulatory and GxP requirements.

The contingent will support the Clinical Data Layer initiative within the Ruby Program and act as the key interface between business stakeholders and the technical implementation partner. The role combines Business Analysis, Delivery Coordination, Stakeholder Management, and Business Engagement activities.

Typical Day

• Facilitate workshops with business stakeholders
  
• Gather, analyze, prioritize, and document requirements
  
• Manage and maintain the business backlog
  
• Coordinate with the external implementation partner
  
• Act a delivery counterpart and business representative
  
• Support UAT preparation and business validation activities
  
• Drive stakeholder engagement and communication
  
• Organize approvals and alignment across stakeholder groups
  
• Support business adoption and training activities
  

Main stakeholders include:

• Clinical Data Managers
  
• Statistical Programmers
  
• Biometrics teams
  
• Clinical Operations stakeholders
  

Requirements

Years of Experience

• Ideally 8+ years of experience
  
• However, the manager is flexible for candidates with fewer years if they demonstrate strong and relevant hands-on experience in similar clinical data initiatives
  

Must Have

• Strong Pharmaceutical / Life Sciences industry experience
  
• Clinical Data domain expertise
  
• Deep understanding of Clinical Trial Lifecycle
  
• Knowledge of CDISC standards
  
• Experience working with:
  
• Clinical Data Management
  
• Biostatistics / Statistical Programming teams
  
• Experience gathering and managing business requirements
  
• Backlog management experience
  
• Stakeholder management and workshop facilitation
  
• Familiarity with Agile methodologies and Azure DevOps environments
  
• Understanding of GxP-regulated environments
  
• Strong communication and coordination skills
  

  Ideal Candidate

A candidate who has already delivered a Clinical Data Platform / Clinical Data Layer implementation in another pharmaceutical company.

Someone who can act as:

• Senior Business Analyst
  
• Delivery Lead
  
• Product-oriented business representative
  

and who can immediately understand the challenges of Clinical Data Management, Biometrics, and Clinical Development organizations.

Nice to Have

• Previous experience working on Clinical Data Layer or Data Platform transformation programs
  
• Experience collaborating with system integrators or implementation partners
  
• Change management and training experience
  
• Product ownership experience
  

Language Requirements

• English mandatory
  
• French and/or Dutch are not required