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