Clinical Operations Manager - Regulatory - Spain

Location: Madrid, Spain

Company

Provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements, and oversee clinical research payments and reconciliations.
• Execute and oversee clinical trial country submissions, approvals, local-language materials, informed consents, and interactions with IRBs/IECs and regulatory authorities.
• Manage country deliverables, timelines, milestones, quality, compliance, supplies, filing, archiving, insurance, and country information in clinical and finance systems.
• Coordinate with Project Managers, CTAs, CRAs, headquarters, finance, legal, regulatory affairs, pharmacovigilance, vendors, sites, and country operations.
• Support local vendors, contribute to SOPs and improvement initiatives, and act as a process subject matter expert, mentor, and trainer.

Requirements

• Spanish speaker required.
• Strong experience in regulatory affairs, contracts, and budgets.
• Digital and AI competencies, including the effective use of digital tools and AI solutions to improve productivity and work quality.
• Ability to ensure compliance with ICH/GCP, country regulations, sponsor procedures, quality standards, and adverse event reporting requirements.
• Ability to coordinate cross-functional stakeholders and deliver country-specific clinical trial commitments.

Nice to have

• Experience managing clinical research payments.

Culture & Benefits

• Fixed-term employment opportunity.
• Work within a global clinical research and healthcare intelligence organization.
• Collaboration with international headquarters, country operations, vendors, sites, and regulatory bodies.
• Inclusive workplace focused on diversity, belonging, and equal opportunity.