Clinical Operations Manager - Regulatory, Spain

About the role

This fixed-term position is accountable for performance and compliance of assigned protocols in a country, in line with ICH/GCP and country regulations, sponsor policies, quality standards and adverse event reporting requirements. Under the line manager's oversight, the role covers budget and finance aspects, execution and oversight of clinical trial country submissions and approvals, and ensures site readiness. It suits a Spanish speaker.

Key responsibilities

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements (CTRA), and track clinical research payments, including reconciliation at study close-out.
• Execute and oversee country submissions and approvals for assigned protocols, develop local informed consents and translations, and interact with IRB/IEC and the regulatory authority.
• Manage country deliverables, timelines and results, and own quality and compliance in assigned protocols.
• Contribute to local SOPs, coordinate with the project manager, CTA and CRA, and liaise with headquarters on country timelines.
• Support local vendors, manage clinical and ancillary supplies, import/export, destruction, filing, archiving, retention and insurance processes, and update country data in clinical and finance systems.
• Influence investigators and partners, work with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional teams, and contribute to or lead value-adding projects.
• Act as subject matter expert, mentor and trainer, and share best practices.

Required profile

• Strong experience in regulatory, contracts and budgets.
• Digital and AI competencies, with the ability to use digital tools and AI solutions to improve productivity and work quality.
• Nice to have: experience in payments.
• Spanish speaking.