Senior Clinical Trial Manager

Position Overview:

• You will oversee the planning, execution, and completion of Peptilogics' clinical trials, focusing on the RETAIN Phase 2/3 registrational trial for PLG0206.
• Reporting to the Director of Clinical Operations, you will manage CROs and trial vendors to ensure project objectives are met within budget and timeline.

Key Responsibilities:

• Manage day-to-day operations of clinical trials, facilitating internal team meetings and serving as the primary CRO contact.
• Monitor and track study performance metrics, budgets, and timelines, ensuring compliance with GCP and regulatory standards.
• Review TMF files and ensure inspection readiness, while continuously monitoring quality and implementing corrective actions.

Required Qualifications:

• You have a bachelor's degree in life sciences and a minimum of 12 years of clinical research experience with late-stage multinational trials.
• Strong communication, organization, and prioritization skills, with a proactive approach and ability to hold teams accountable.
• Proficiency in clinical trial management systems, Microsoft Office, and working knowledge of GCP, FDA regulations, and ICH guidelines.