Clinical Operations Manager - Start-Up Lead

About the role

ICON Strategic Solutions is hiring a Clinical Operations Manager (Start-Up Lead) for a home-based role in Madrid. Working in a sponsor-dedicated model, the role is accountable for performance and compliance of assigned protocols under ICH/GCP and local regulations, covering budget and finance, country submissions and approvals, and ensuring site readiness.

Key responsibilities

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements (CTRA), track payments and reconcile them at study close-out
• Oversee FCPA, DPS/OFAC compliance and maintain financial systems; forecast budgets with headquarters functions
• Execute and oversee country submissions and approvals, manage country deliverables, timelines and results, and contribute to local SOPs
• Develop local-language informed consents and translations, and liaise with IRB/IEC and the regulatory authority
• Coordinate with CTM, CTA, CRA, finance and legal teams, and provide support and oversight to local vendors
• Manage local supply processes, imports and exports, destruction, filing, archiving, retention and insurance
• Influence investigators, partners and country operations to meet budget targets and payment timelines, and act as subject matter expert and mentor

Required profile

• 5-7 years of experience in clinical research, or combined experience in clinical research and finance/business
• Strong ability to influence investigators, vendors and partners and to make independent decisions with limited oversight
• Willingness to travel approximately 25%
• Legal right to work in the country where the role is based

Required skills

• Expertise in core clinical systems, tools and metrics
• Budget and contract negotiation, and knowledge of local regulatory environments and submission/approval processes
• Excellent verbal and written communication and mentoring skills in Spanish and English

What we offer

• Competitive base salary and performance-related incentives
• Health, dental and vision coverage where applicable, retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities