Overview
In this fully remote role, you will provide GCP compliance guidance to clinical study teams and partners, prioritizing risks to protect study quality. You will act as a trusted advisor across R&D; and external vendors, shaping actions to address quality issues and support inspections. You'll lead risk-based compliance activities, drive CAPAs, and foster a culture of quality across the organization. This is a value-driven opportunity to contribute to clinical development solutions that benefit patients, with an emphasis on collaboration and regulatory excellence.
Responsabilidades Provide GCP and regulatory guidance to clinical study teams
Lead risk-based compliance assessments and prioritize activities
Escalate significant quality issues to leadership
Participate in CRO/vendor governance and vendor evaluations as SME
Support CAPA development and responses to audit findings




Coordinate quality management system activities including deviations and root cause analysis
Lead inspection readiness and ensure training for project teams
Collaborate with cross-functional teams to address trend-based quality improvements
Requisitos principales Minimum 5 years in clinical operations or compliance roles (clinical trial manager, clinical project manager, etc.)
Experience in clinical compliance, quality assurance, or regulatory compliance
Thorough knowledge of drug development and clinical trial process
Strong understanding of regulatory and ICH GCP requirements and international regulations
Working knowledge of CAPA management, risk management, and regulatory inspections
Collaborative mindset
Stakeholder management
Proactive problem-solving
GCP knowledge
ICH guidelines understanding
CAPA management

📌 Clinical Compliance Manager (Santiago de Compostela)
🏢 Parexel
📍 Santiago de Compostela