Senior Business Analyst - Clinical Data Layer
Overview
We are partnered with a global biopharmaceutical organisation seeking an experienced Senior Business Analyst to support a Clinical Data Layer transformation programme.
This role will support the delivery of a modern, governed clinical data environment, acting as the key interface between business stakeholders and an external implementation partner. Working closely with Clinical Data Management, Biometrics, Statistical Programming and Clinical Operations teams, you will help drive requirements gathering, stakeholder engagement, backlog management and business adoption activities.
Requirements
- Facilitate workshops and requirements gathering sessions with business stakeholders.
- Gather, analyse, document and prioritise business requirements.
- Manage and maintain the business backlog within an Agile environment.
- Coordinate activities between business stakeholders and implementation partners.
- Act as the business representative throughout the delivery lifecycle.
- Support user acceptance testing and business validation activities.
- Drive stakeholder engagement, communication and alignment across teams.
- Support business adoption, training and change activities.
Hard Skills
- Strong experience within the pharmaceutical or life sciences industry.
- Clinical Data Management and Clinical Data domain expertise.
- Deep understanding of the clinical trial lifecycle.
- Knowledge of CDISC standards.
- Experience working with Clinical Data Management, Biostatistics and Statistical Programming teams.
- Experience gathering and managing business requirements.
- Backlog management experience within Agile delivery environments.
- Experience with Agile methodologies and Azure DevOps.
- Understanding of GxP-regulated environments.
Soft Skills
- Excellent stakeholder management and relationship-building skills.
- Strong workshop facilitation and communication abilities.
- Ability to drive alignment across cross-functional teams.
- Strong organisational and prioritisation capabilities.
- Delivery-focused mindset with strong coordination skills.
- Comfortable working within complex global environments.
Qualifications
- Ideally 8+ years of Business Analysis experience within a pharmaceutical or life sciences environment.
- Experience supporting Clinical Data Management, Biometrics or Clinical Development functions.
- Previous experience delivering a Clinical Data Platform or Clinical Data Layer implementation would be advantageous.
- Experience acting as a Senior Business Analyst, Delivery Lead or Product-oriented business representative would be beneficial.