Overview
Clinical Trials Specialist Jobs in Cork, County Cork, Ireland at Morgan McKinley
Title: Clinical Trials Specialist
Company: Morgan McKinley
Location: Cork, County Cork, Ireland
12 Month Contract (Potential to extend) – Senior/Principal Quality Associate
Partner with cross-functional operational teams in the development and implementation of clinical quality activities. Deliver quality system outputs (deviation management, root cause investigations, CAPA implementation), provide quality oversight, support audit/inspection readiness, and drive compliance and continuous improvement.
Primary Responsibilities
- Implement and Manage Quality Systems:
- Develop, review, and approve area-specific procedures, tools, and quality system documents.
- Provide consultation on GCP requirements, regulatory standards, and procedure interpretations.
- Manage deviations, change controls, and management notifications, ensuring escalation and timely resolution.
- Guide root cause analyses, CAPA design/approval, risk assessments, and self-inspections.
- Support quality management for third parties and business partners.
- Provide Quality Oversight:
- Monitor quality compliance, anticipate gaps, and propose proactive solutions.
- Execute quality plans, track compliance metrics, analyze trends, and present updates to stakeholders.
- Lead process improvement initiatives and oversee CAPA/deviation completion.
- Audits and Inspections:
- Support audit and regulatory inspection readiness, execution (front/back room support), and response coordination.
- Ensure completion and timely resolution of corrective action plans.
- Cross-Functional Collaboration:
- Act as the primary quality contact for operational units, establishing strong cross-functional partnerships.
- Apply a risk-based approach to guide business decisions and share best practices.
- Support BQA responsibilities for validated IT systems as assigned, including document review and change management.
Minimum Qualifications
- Bachelor’s degree in a scientific, healthcare, or related field (or equivalent work experience).
- 5+ years of experience working in a Good Clinical Practice (GCP) regulated environment.
- Demonstrated experience managing medical/clinical quality systems.
- Strong project management, critical thinking, problem-solving, and communication skills.
- Proven ability to manage multiple priorities and work cross-functionally.
Preferred Qualifications
- Master’s degree.
- Direct Quality Assurance (QA) or Quality Control (QC) experience.
- Background in clinical operations, regulatory affairs, or medical writing.
- Experience operating within global or regional organizational structures.
