Regional Clinical Study Manager

This is a fully remote position, open to applicants in France.

📋 Description

• Responsible for the delivery of regional studies, ensuring inspection-ready quality is maintained within established timelines and budget constraints.

• Lead the regional clinical operations team and serve as the primary point for resolving issues.

• Guarantee that regional deliverables are in line with the overall objectives of the study.

• Collaborate with key stakeholders in the region and provide consistent updates regarding study progress.

• Create, manage, and uphold high-quality timelines for study start-up and recruitment in the region.

• Ensure that local adaptations of global study documents and submissions to regulatory authorities are available promptly.

• Work closely with Clinical Research Associates (CRAs) in the region to facilitate effective study execution at various sites.

• Address escalated issues or challenges arising with sites in the region.

• Oversee regional study activities to ensure compliance with the study protocol, standard operating procedures (SOPs), and ICH-GCP guidelines.

⛳️ Requirements

• A Bachelor’s degree in a scientific or healthcare-related field is required; an advanced degree is preferred.

• At least 4 years of progressive experience in clinical research within biotech, pharmaceutical, or CRO settings.

• Demonstrated experience in clinical research, including relevant background as a team lead in clinical functions.

• Clinical Research Associate (CRA) experience is preferred.

• Proficient in Microsoft Word, Excel, MS Project, PowerPoint, and Outlook.

🏝️ Benefits

• Health insurance

• Professional development

• Flexible work arrangements

• Paid time off

• Wellness programs

• Performance-based feedback