Global Site Start-Up, Regulatory & Contracts Manager

Fortrea; Madrid; On-site; EUR 60,000 - 85,000; Full time

Job summary

Fortrea in Madrid seeks a Site Regulatory & Contract Manager to lead country-level study start-up activities. You will oversee regulatory submissions, approvals, and contract negotiations to initiate trials on schedule.

This role requires strong project management, budgeting, and cross-functional coordination with CRAs, regulatory, legal, finance, sites, and sponsors. Fluent English and excellent communication are essential.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 5 years in site regulatory/contract management or start-up roles.
• Strong knowledge of regulatory submissions, site activation, budgets, and contracts.
• Solid knowledge of ICH-GCP and local regulatory requirements.
• Proven project management and stakeholder management skills.
• Ability to manage multiple studies in a fast-paced global environment.
• Fluent English and strong communication skills.

Responsibilities

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

Skills

Regulatory submissions

Contract negotiations

Budget oversight

Project management

Stakeholder management

Communication

Problem-solving

Education

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

Job description

Fortrea in Madrid seeks a Site Regulatory & Contract Manager to lead country-level study start-up activities. You will oversee regulatory submissions, approvals, and contract negotiations to initiate trials on schedule.

This role requires strong project management, budgeting, and cross-functional coordination with CRAs, regulatory, legal, finance, sites, and sponsors. Fluent English and excellent communication are essential.