Global Site Start-Up & Regulatory Contracts Lead

FTSPA Fortrea Spain S.A; Madrid; On-site; EUR 70,000 - 110,000; Full time

Job summary

Fortrea Spain S.A. seeks a Site Regulatory & Contract Manager to lead country-level study start-up and regulatory submissions, ensuring trials activate on time and within budget.

You will coordinate with Clinical Trial Coordinators, CRAs, regulatory, legal, finance and vendors, manage CTRAs and oversee quality, risk, and timelines across multiple studies in a global environment. Fluent English and strong communication skills are required, with a track record in regulatory excellence and

Qualifications

• Bachelor's degree in a life sciences, healthcare, business, finance or related field.
• Proven project management, stakeholder management, communication and problem-solving skills.
• Ability to manage multiple studies and priorities in a fast-paced global environment.

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 milestones are met.
• Drive site readiness and ensure country deliverables are completed on time.
• Maintain oversight of quality, compliance, and risk management during start-up.
• Build relationships with sites, Ethics Committees, Regulatory Authorities and internal stakeholders.

Skills

Project management

Stakeholder management

Communication

Problem solving

Multitasking

Fluent English

Education

Bachelor's Degree in Life Sciences, Healthcare, Business Administration, Finance, or a related field

Job description

Fortrea Spain S.A. seeks a Site Regulatory & Contract Manager to lead country-level study start-up and regulatory submissions, ensuring trials activate on time and within budget.

You will coordinate with Clinical Trial Coordinators, CRAs, regulatory, legal, finance and vendors, manage CTRAs and oversee quality, risk, and timelines across multiple studies in a global environment. Fluent English and strong communication skills are required, with a track record in regulatory excellence and