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 (Lérida)
🏢 Parexel
📍 Lérida