Clinical Operations

• Support initiative sponsors during the Opportunity and Feasibility phases before project implementation
• Clarify business needs, objectives, and expected value of new initiatives
• Identify and map impacted business processes, systems, and stakeholders
• Lead workshops with Business, IT, and senior stakeholders
• Assess project feasibility, risks, dependencies, and key success factors
• Define required resources, budget estimates, and governance
• Develop high-level project roadmaps and recommendations
• Deliver structured project framing and feasibility documentation to support decision-making

Project Manager, Clinical Systems

• Lead local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendment submissions
• Independently prepare and manage submissions to Ethics Committees and Regulatory Authorities
• Complete and maintain XML documentation as required for submissions
• Prepare informed consent forms using approved templates
• Ensure compliance with ICH/GCP, country regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements
• Apply in-depth knowledge of the local regulatory environment, submission processes, and approval pathways to support study startup activities
• Manage investigational medicinal product-related local supply activities, including coordination with vendors providing background medications and standard of care supplies
• Review and validate translated study documents
• Support protocol performance and compliance activities across assigned studies within France
• Collaborate with study teams and stakeholders to facilitate timely regulatory approvals and study progress

Clinical Operations jobs in France

Project Manager, Clinical Systems

Regulatory & Submissions Lead – Clinical Operations Manager