Clinical Trial Manager (CTM) – FSP

About the role

The Clinical Trial Manager (CTM) will lead the delivery of clinical studies of low to moderate complexity, ensuring clean, evaluable data are produced on time and within budget. Working closely with project managers, clinical teams and external sites, the CTM guarantees that all deliverables meet the customer’s quality, cost and timeline expectations.

Key responsibilities

• Manage all operational and quality aspects of assigned studies in compliance with ICH GCP.
• Develop and maintain monitoring plans, guidelines and other clinical tools.
• Oversee the set‑up, organization and quality of the Trial Master File (local and central).
• Participate in the design of CRFs, informed consent templates and related protocol documents.
• Collaborate with project managers to prepare client presentations, bid defenses and hand‑off meetings.
• Lead team meetings, monitor timelines, resources and quality metrics, and implement corrective actions when needed.
• Train and enforce standardized monitoring processes across the study.
• Ensure timely archiving of study documents and materials.
• Monitor project financials and, in smaller regions, conduct Accompanied Field Visits.

Required profile

• Proven experience managing clinical trials of low to moderate complexity.
• Strong understanding of ICH GCP and clinical research regulations.
• Excellent organizational and communication skills, with the ability to lead cross‑functional teams.
• Ability to work autonomously while maintaining alignment with project goals.

Required skills

• ICH GCP compliance
• Clinical monitoring
• Trial Master File management
• CRF design and development
• Data Quality Plan creation