Senior Business Analyst - Clinical Data Layer

Pauwels Consulting; Eigenbrakel; On-site; EUR 70,000 - 100,000; Full time

Job summary

A leading biopharmaceutical organization in Belgium is seeking a Senior Business Analyst to transform their clinical data landscape into a governed, central framework. You will liaise between business stakeholders and technical partners to ensure regulatory compliance.

You will facilitate workshops, manage the backlog, coordinate with external partners, and serve as the primary business representative for clinical data management and biostatistics teams.

Qualifications

• 8+ years of experience in the pharmaceutical or life sciences industry with a focus on clinical data initiatives.
• Deep expertise in the Clinical Trial Lifecycle, Clinical Data Management, and Biostatistics.
• Strong understanding of CDISC standards and experience working within GxP-regulated environments.
• Proven experience in backlog management, stakeholder management, and workshop facilitation.
• Familiar with Agile methodologies and working within Azure DevOps environments.
• Fluent in English.

Responsibilities

• Facilitate workshops with business stakeholders to gather, analyze, and document complex requirements.
• Manage the business backlog and coordinate delivery activities with external implementation partners.
• Act as the primary business representative for clinical data management and biostatistics teams.
• Support UAT preparation and business validation activities to ensure technical solutions meet operational needs.
• Drive stakeholder engagement and communication across clinical operations and biometrics groups.
• Organize necessary approvals and support business adoption through training and communication initiatives.

Skills

Backlog management

Stakeholder management

Workshop facilitation

Agile methodologies

Azure DevOps

English

Job description

Our client, a leading biopharmaceutical organization, is seeking a Senior Business Analyst to support the transformation of their clinical data landscape into a governed, central framework. This role involves acting as a key interface between business stakeholders and technical partners to ensure compliance with regulatory standards.

• Facilitate workshops with business stakeholders to gather, analyze, and document complex requirements.
• Manage the business backlog and coordinate delivery activities with external implementation partners.
• Act as the primary business representative for clinical data management and biostatistics teams.
• Support UAT preparation and business validation activities to ensure technical solutions meet operational needs.
• Drive stakeholder engagement and communication across clinical operations and biometrics groups.
• Organize necessary approvals and support business adoption through training and communication initiatives.

• You have 8+ years of experience in the pharmaceutical or life sciences industry with a focus on clinical data initiatives.
• You possess deep expertise in the Clinical Trial Lifecycle, Clinical Data Management, and Biostatistics.
• You bring a strong understanding of CDISC standards and experience working within GxP-regulated environments.
• You have proven experience in backlog management, stakeholder management, and workshop facilitation.
• You're familiar with Agile methodologies and working within Azure DevOps environments.
• You are fluent in English.

Nice to Haves

• Previous experience with Clinical Data Layer or Data Platform implementations.
• Experience in change management, training, or Product Ownership.
• Collaboration with system integrators or implementation partners.