Regional Clinical Study Manager

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

📋 Description

• Responsible for the delivery of regional studies with a focus on maintaining inspection-ready quality, adhering to timelines and budget constraints.

• Lead the regional clinical operations team and supervise external partners in the region.

• Serve as the key escalation point for issues related to assigned studies.

• Ensure alignment of regional deliverables with the overall objectives of the study.

• Oversee planning and management of studies from feasibility through to closeout.

• Manage timelines for start-up and recruitment, while tracking regional progress.

• Facilitate trial feasibility assessments, country allocation, and site selection processes.

• Coordinate local adaptations of global study documents and submissions for regulatory/ethics approval.

• Maintain accurate and up-to-date regional and country information within study systems.

• Collaborate with CRAs to ensure effective site execution and review/sign off on monitoring reports.

• Ensure that country- and site-level Trial Master Files are established, maintained, and undergo quality control.

• Provide insights on clinical supplies, drug inventories, labels, approvals for comparator drugs, and reimbursement statuses.

• Oversee regional data collection, data entry, and resolution of queries.

• Assist in the planning and execution of Clinical Study Reports.

• Monitor adherence to protocols, standard operating procedures (SOPs), ICH/GCP guidelines, and relevant regulations.

• Ensure readiness for regional inspections and prepare sites for audits and inspections.

• Share insights and best practices to enhance study efficiency and quality.

• Select and manage regional vendors and associated budgets.

• Oversee investigator fees, site payments, and reimbursement activities for patient travel.

• Identify resource requirements, develop contingency plans, and monitor resource usage.

• Provide performance feedback and mentorship to junior team members.

• Directly manage study start-up and trial-monitoring personnel, including work allocation, performance evaluations, input on hiring, and development planning.

⛳️ Requirements

• A Bachelor’s Degree in a scientific or healthcare field is required; a higher degree is preferred.

• Exceptions may be considered for candidates with pertinent clinical operations experience.

• A minimum of 4 years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO sectors.

• Demonstrated experience in clinical research, including relevant leadership experience in clinical functions.

• Previous experience as a Clinical Research Associate (CRA) is preferred.

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

• Willingness to travel as necessary to meet business needs.

🏝️ Benefits

• Salary range of 74,100.00 EUR - 92,600.00 EUR.

• Travel may be required based on business needs.

• Mentoring and support for professional development available for direct reports.