[Hiring] Site Regulatory & Contract Manager @Fortrea

Role 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.

• 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.

Qualifications

• 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.

Requirements

• Experienced regulatory and start-up professional who can successfully drive regulatory, contractual, financial, and operational activities.
• Ability to ensure studies are activated efficiently and compliantly.
• Combines strong project management capabilities with a deep understanding of the clinical trial start-up environment.