Site Regulatory & Contract Manager - FSP Model - Madrid

Fortrea; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

Fortrea is seeking a Site Regulatory & Contract Manager to lead country-level regulatory submissions, study start-up activities, and contract negotiations. The role coordinates with cross-functional teams to ensure timely activation, budget oversight, and ongoing compliance, while building strong relationships with Ethics Committees and Regulatory Authorities in a fast-paced global environment.

The ideal candidate holds a Bachelor’s degree in Life Sciences or related field, 5+ years in

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Business Administration, Finance, or related field.
• Minimum 5 years of experience in site regulatory and contract management or comparable 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 and stakeholder management skills.
• Ability to manage multiple studies and priorities in a fast-paced global environment.
• Fluent English and strong communication skills.

Responsibilities

• Lead country-level regulatory submissions, approvals, and study start-up activities.
• Manage study budgets, CTRAs, and financial oversight activities.
• Coordinate with Clinical Trial Coordinators, CRAs, regulatory, legal, finance, vendors, and global study teams.
• Drive site readiness and ensure country deliverables meet timelines.
• Maintain oversight of quality, compliance, and risk management during start-up.
• Build strong relationships with sites, Ethics Committees, Regulatory Authorities, and stakeholders.
• Contribute to process improvements and training initiatives.

Skills

Regulatory submissions

Contract negotiations

Budget management

Stakeholder management

Project management

Quality & compliance

Regulatory knowledge

Education

Bachelor’s Degree in Life Sciences

Job description

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.