Senior Business Analyst
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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
- Clinical
Data Management
- 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
-
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