Job description

Job Title: Project Manager / Business Analyst - Clinical Systems (PM/BA)
Location: Cork, Ireland (Onsite - 3 days per week)
Job Type-Contract

About Our Client

Our client is a global leader in pharmaceutical innovation, focused on advancing cutting-edge science to improve health outcomes worldwide. With a strong commitment to digital transformation, they are investing heavily in building AI-enabled, automated clinical research ecosystems that accelerate the delivery of life-changing therapies.
As part of this transformation, they are expanding their Clinical Capabilities organization and seeking talented professionals who can help drive innovation, operational excellence, and secure, compliant clinical system delivery.

Role Summary

We are seeking a Project Manager / Business Analyst (PM/BA) to support the transformation toward an AI-enabled clinical trial ecosystem.
In this role, you will be embedded within the Clinical Capabilities organization, driving project execution, system enhancements, validation activities, and compliance alignment across key proprietary clinical applications.
You will collaborate closely with system owners, subject matter experts, engineering teams, and global stakeholders to ensure secure, compliant, and controlled delivery of system changes and operational improvements.

Example Business Applications Supported

This role will support several enterprise clinical and statistical systems, including:

Clinical Lab Data & Study Activation Platform - Core proprietary application used across clinical trials for lab data ingestion, reference table standards, study activation/deactivation workflows, and downstream data delivery. Supports complex integrations, governed code creation (e.g., central lab test codes, performing lab codes, ECG codes), and publication workflows.
Statistical Computing Environment - Large-scale data lake environment used for statistical analysis and research data workflows.
Blinding Application - Secure system designed to protect study integrity by masking placebo treatments from trial facilitators.
Statistical Template Platform - Proprietary system that creates standardized templates for statistical analysis.

The role requires an understanding of supporting both SaaS platforms and internally built (greenfield) applications, covering new feature development through production support.

Key Responsibilities

Project & Delivery Management

Lead and coordinate project workstreams related to system enhancements, environment upgrades, workflow automation, and operational improvements.
Develop and maintain project plans, timelines, RAID logs, and stakeholder communications.
Facilitate requirements gathering, scope definition, prioritization, and change control.
Support release planning, deployment readiness, and post-release validation activities.

Business Analysis & Requirements

Translate business needs into functional requirements, user stories, and acceptance criteria.
Document current-state and future-state workflows for clinical systems and lab data processes.
Partner with system owners to define governance frameworks, data standards, and process improvements.
Conduct impact assessments for new features, integrations, and system changes.

System Validation & Compliance

Coordinate validation activities including IQ/OQ/PQ testing, test planning, and execution.
Ensure alignment with quality, security, and regulatory frameworks.
Maintain validation documentation, traceability matrices, and audit-ready artifacts.
Support periodic access reviews, security assessments, and compliance reporting.

Cross-Functional Collaboration

Work closely with application development, engineering, and data standards teams to deliver enhancements and resolve defects.
Partner with Tier 1 and Tier 2 support teams to analyze recurring issues and drive root-cause resolution.
Communicate effectively with global stakeholders, including non-technical and non-native English-speaking audiences.

Operational & System Ownership Support

Assist system owners with roadmap planning, release coordination, and lifecycle management.
Support ServiceNow workflow optimization, request intake processes, and automation initiatives.
Contribute to documentation, SOP updates, and knowledge management for clinical systems.
Participate in post-incident reviews and continuous improvement initiatives.

Required Qualifications

3+ years of experience in IT/Systems Project Management, Business Analysis, or Systems Delivery roles.
Experience supporting enterprise, research, or proprietary applications.
Strong requirements gathering, documentation, and stakeholder management skills.
Familiarity with SDLC, Agile methodologies, and change control processes.
Experience supporting system validation in regulated environments (GxP / CSV).
Understanding of secure access management (IAM, MFA, RBAC) and compliance frameworks.
Ability to manage multiple priorities and work independently in a fast-paced environment.

Technical & Domain Skills

Exposure to clinical systems, laboratory data workflows, or structured data environments.
Familiarity with ServiceNow or similar ITSM platforms.
Understanding of system integrations, APIs, and data formats (JSON/XML).
Experience with cloud or containerized environments (AWS, Docker) is beneficial.

Preferred Qualifications

Experience with LabsConnect, LIMS, or clinical data platforms.
Knowledge of CDISC or laboratory data standardization frameworks.
Background in biology, chemistry, clinical research, or health sciences.
Experience supporting study-based or regulated computing environments.
Familiarity with scripting or automation tools (Python, Bash).

Please contact Nidhi at +353 1 645 5244 or
email [email protected].