Freelance Regional Clinical Trial Manager

About the role

Rho is seeking a Freelance Regional Clinical Trial Manager to lead clinical trial operations across multiple sites. You will ensure regulatory compliance, manage budgets and timelines, and collaborate closely with investigators and clinical staff.

Key responsibilities

• Plan and execute study start‑up to achieve rapid site initiation.
• Coordinate CRO assignment and support contracting with Purchasing and Vendor Management.
• Manage on‑site logistics, including IVRS/IWRS (IXRS) systems, IMP supply, equipment, and lab coordination with the Clinical Trial Supply Unit (CTSU).
• Develop and maintain the Investigator Budget Tool and support contract management.
• Prepare Clinical Trial Master File (CTMF) and Investigator Site File (ISF) in collaboration with internal interfaces.
• Submit initial and ongoing documentation to Ethics Committees (ECs) and Competent Authorities (CAs) and monitor approval progress.
• Participate in Investigator Meetings and supervise on‑site monitoring activities.
• Monitor study budget, anticipate changes, and communicate adjustments.
• Drive regional patient recruitment, retention, and timeline adherence.
• Perform co‑monitoring visits to verify data quality.

Required profile

• Proven experience in clinical trial operations and site management.
• Strong knowledge of regulatory requirements for Ethics Committees and Competent Authorities.
• Ability to manage budgets, timelines, and multi‑site logistics.
• Excellent communication with investigators, CROs, and internal teams.

Required skills

• IVRS/IWRS (IXRS) system management.
• Clinical Trial Supply Unit (CTSU) coordination.
• Investigator Budget Tool development.
• Clinical Trial Master File (CTMF) preparation.
• Regulatory submission to ECs and CAs.
• Site monitoring and co‑monitoring visit execution.

What we offer

• Freelance contract of approximately 156 hours per month.
• Engagement until the end of 2026 with annual renewal based on performance.
• Opportunity to contribute to studies that improve global health outcomes.