Aligned Automation Services Pvt Ltd | Contract
Business Analyst - Digital Trial Foundations (DTF)
Cork city, Ireland | Posted on 04/06/2026
This role sits withinthe
Clinical Trial Foundations (CTF)
team, which enables and advancesthe
technology and processes underpinning clinical trial execution
.
Theteam collaborates with stakeholders across clinical operations, technology, andquality to identify opportunities for
digitization, automation, and processoptimization
, and translates these into scalable solutions.
The
DTF BusinessAnalyst
will focus on
Digital Trial Foundations (DTF)
systems andprocesses, driving requirements analysis, process improvement, and digitaltransformation initiatives across the clinical trial landscape.
Position Summary
The DTF BusinessAnalyst will play a critical role in
bridging business needs and technologysolutions
.
This includes gathering and analyzing requirements, mappingprocesses, identifying optimization opportunities, and supporting systemenhancements across the DTF portfolio.
The ideal candidatebrings strong
business analysis capabilities
, combined with experiencein
clinical or regulated environments
, and a pragmatic approach todelivering measurable improvements in trial execution and digital maturity.
Key Responsibilities
1. StakeholderEngagement & Requirements Management
Lead engagement with business andtechnical stakeholders to elicit, analyze, and validate requirements.
Business requirements
Functional specifications
Use cases and user stories
Process workflows
Ensure alignment between businessobjectives and technology solutions.
Capture and communicate internal andexternal customer needs related to system performance and processeffectiveness.
Analyses user feedback and identify trends,risks, and improvement opportunities.
2. ProcessImprovement & Digital Optimization
Lead
process mapping and gap analysis
across clinical trial workflows.
Identify and drive opportunities for
digitaloptimization and automation
.
Continuously enhance system functionalityand operational efficiency.
Maintain strong awareness of:
Organizational systems landscape
Collaborate across functions, geographies,and vendor teams to implement improvements.
3. System Support& Operational Delivery
Identify system risks, issues, anddependencies; elevate appropriately.
Support system testing activities (e.g.,UAT, validation support).
Perform data movement and ensure qualitychecks and data integrity.
Develop and maintain dashboards andmetrics to support operational oversight and decision-making.
4. Quality,Compliance & Knowledge Management
Support internal audits and externalregulatory inspections.
Ensure alignment with regulatory andquality standards in all deliverables.
Develop and maintain:
Training materials
Job aids and SOP support documents
FAQs and knowledge base content
Promote knowledge sharing and bestpractices across teams.
Minimum Qualifications
Bachelor's degree in
Science,Information Technology, or a related field
(or equivalent experience).
Experience in one or more of thefollowing:
Medical or quality systems
Clinical data or information flow
Strong written and verbal communicationskills.
Proven analytical and problem-solvingabilities.
Ability to perform root cause analysis andimplement corrective actions.
Strong organizational and time managementskills.
Ability to manage multiple priorities in adynamic environment.
Preferred Qualifications
Advanced degree in a relevant discipline.
Experience in a
clinical,pharmaceutical, or regulated (GxP) environment
.
Hands-on experience with
clinical trialsystems and digital platforms
.
Experience with:
Requirements management tools
Process modelling frameworks (e.g., BPMN)
Project management methodologies
Understanding of regulatory and qualityframeworks governing clinical trials.
Demonstrated ability to:
Influence cross-functional teams
Build consensus and resolve conflicts
Strong critical thinking anddecision-making skills.
High adaptability and learning agility.
Customer-focused mindset with strongcollaboration skills.
Business Analysis & RequirementsEngineering
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