Global Site Start-Up & Regulatory Manager

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

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