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 - Spain/Poland - FSP (Castilla y León)
🏢 Parexel
📍 Castilla y León