Clinical Trial Start-Up Lead: Regulatory & Contracts

Fortrea; Madrid; On-site; EUR 75,000 - 105,000; Full time

Job summary

Fortrea in Madrid seeks an experienced Site Regulatory & Contract Manager to lead country-level study start-up activities, ensuring trials are initiated on time, within budget, and in compliance with regulations and quality standards.

The role requires at least 5 years of regulatory and start-up experience, strong project and stakeholder management, and fluent English. You will interact with Ethics Committees, Regulatory Authorities, and internal teams to drive milestones.

Qualifications

• Bachelor's degree required in Life Sciences, Healthcare, Business Administration, Finance, or related field.
• Minimum 5 years of experience as site regulatory and contract manager or similar start-up role.
• Solid knowledge of ICH-GCP and local regulatory requirements.

Responsibilities

• Lead country-level regulatory submissions, approvals, and study start-up activities.
• Manage study budgets, CTRAs, and financial oversight.
• Coordinate with Clinical Trial Coordinators, CRAs, regulatory, legal, finance, vendors, and global teams.
• Drive site readiness and ensure country deliverables are on time.

Skills

Project management

Stakeholder management

Communication skills

Problem-solving

Fluent English

Education

Bachelor's degree in Life Sciences/Healthcare/Business Administration/Finance

Job description

Fortrea in Madrid seeks an experienced Site Regulatory & Contract Manager to lead country-level study start-up activities, ensuring trials are initiated on time, within budget, and in compliance with regulations and quality standards.

The role requires at least 5 years of regulatory and start-up experience, strong project and stakeholder management, and fluent English. You will interact with Ethics Committees, Regulatory Authorities, and internal teams to drive milestones.