Clinical Operations SOP & Quality Lead
hace 20 horas
Madrid
🚀 Join Crovelis as our Clinical Ops Quality & SOP Lead! At Crovelis, we’re redefining clinical research by blending cutting-edge AI with human ingenuity to accelerate drug development and improve patient outcomes worldwide. We’re a dynamic, mid‑size CRO committed to innovation, collaboration, and agile excellence. 🧭 The Role: Clinical Operations SOP & Quality Lead We’re looking for a motivated and proactive leader to drive Clinical Operations quality and governance. In this pivotal role, you’ll take charge of designing, implementing, and maintaining SOPs, manuals, plans, and procedures for our global ClinOps team—ensuring we meet the highest regulatory, internal, and industry standards through structured internal controls and continuous improvement. 🔍 What You’ll Do • Lead process design: Develop and maintain SOPs, work instructions (WKIs), templates, and training materials., • Ensure compliance: Monitor adherence to SOPs and global regulations alongside ClinOps, escalating to QA when needed., • Manage CAPAs: Drive corrective/preventive action plans post‑audit or inspection., • Cross-functional collaboration: Partner with R&D, GCQU, and ClinOp teams to roll out effective improvements., • Training & development: Design and deliver training programs, track completion via training matrices., • Regulatory updates: Track global changes, update SOPs, and support GCQU., • Audit readiness: Lead end-to-end support for inspections and audits., • Risk management: Collaborate on risk assessment plans with clinical project managers., • Quality oversight: Manage documentation, checkpoints, on-site visits with CRAs, and quality KPIs., • Documentation governance: Regularly review and maintain ClinOps documents., • Ensure GCP compliance across all clinical operations. 🎯 Who You Are • Educational background: Degree in Chemistry, Pharmacy, Biology, or Medicine. A Master’s and GxP/QA experience are a plus., • Language skills: Fluent in Spanish and English; additional languages beneficial., • Professional experience:, • Option 1: 2+ years in Pharma QA + 3+ years in Clinical Ops, • Option 2: 5+ years in Clinical Ops roles within Pharma, • Core competencies: Expert in global clinical regulations, experienced in SOP design., • Personal traits: Proactive, strategic, adaptable, organized, and a strong communicator in multicultural environments. Skilled at training multidisciplinary teams., • Mobility: Willingness to travel up to 30%. 🌟 Why Crovelis? • High-impact role: Shape how we operate and ensure trial excellence on a global scale., • Innovative setting: Be part of a forward-thinking CRO using AI to transform clinical trials, • Career progression: Work alongside industry leaders in a high-growth environment, with full support to develop professionally. If you're ready to lead quality and operational excellence in a rapidly growing, AI‑enabled clinical research organization, Crovelis is the perfect place to make your mark. Let’s transform clinical research together! 💡
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