Site Regulatory & Contract Manager - FSP Model - Madrid
Fortrea · Madrid
The Site Regulatory & Contract Manager is responsible for leading and overseeing country-level study start-up activities, ensuring clinical trials are initiated on time, within budget, and in compliance with applicable regulations and quality standards.
Key Responsibilities
- Lead country-level regulatory submissions, approvals, and study start-up activities.
- Manage study budgets, contract negotiations (CTRAs), and financial oversight activities.
- Coordinate with Clinical Trial Coordinators, CRAs, regulatory, legal, finance, vendors, and global study teams to ensure study milestones are achieved.
- Drive site readiness and ensure all country deliverables are completed according to timelines.
- Maintain oversight of quality, compliance, and risk management activities throughout the start-up phase.
- Build strong relationships with sites, Ethics Committees, Regulatory Authorities, and internal stakeholders.
- Contribute to process improvements, best practice sharing, training, and mentoring initiatives.
Requirements
✔ Bachelor's Degree in Life Sciences, Healthcare, Business Administration, Finance, or a related field.
✔ Minimum 5 years of experience as site regulatory and contract manager or in a comparable clinical study start-up role.
✔ Strong understanding of study start-up processes, regulatory submissions, site activation, budgets, and contract negotiations.
✔ Solid knowledge of ICH-GCP and local regulatory requirements.
✔ Proven project management, stakeholder management, communication, and problem-solving skills.
✔ Ability to manage multiple studies and priorities in a fast-paced global environment.
✔ Fluent English and strong communication skills.
What We're Looking For
We are looking for an experienced regulatory and start up professional who can successfully drive regulatory, contractual, financial, and operational activities while ensuring studies are activated efficiently and compliantly. The ideal candidate combines strong project management capabilities with a deep understanding of the clinical trial start-up environment.
Learn more about our EEO & Accommodations request here.