10 oct
|
Fortrea
|
España
Fortrea seeks a Site Regulatory & Contract Manager to lead country-level clinical trial start-up activities in Madrid. The role involves managing regulatory submissions, study budgets, contract negotiations, and ensuring timely, compliant trial initiation across multiple stakeholders.
Responsibilities
- Lead regulatory submissions, approvals, and country-level study start-up activities
- Manage study budgets, contract negotiations, and financial oversight
- Coordinate across Clinical Trial Coordinators, CRAs, regulatory, legal, finance, and vendor teams
- Ensure site readiness and completion of country deliverables on schedule
- Oversee quality, compliance, and risk management throughout start-up phase
Requirements
- Bachelor's degree in Life Sciences, Healthcare,
Business Administration, Finance, or related field
- Minimum 5 years experience as site regulatory and contract manager or similar clinical trial role
- Deep knowledge of study start-up processes, regulatory submissions, and site activation
- Solid understanding of ICH-GCP and local regulatory requirements
- Strong project management, stakeholder coordination, and problem-solving abilities
- Ability to manage multiple studies concurrently in fast-paced environment
- Fluent English with excellent communication skills
📌 Site Regulatory (España)
🏢 Fortrea
📍 España