Description

You will manage and oversee clinical trials for novel RAS-targeted oncology therapies, including CRO/vendor oversight, study documentation, and site management. You will collaborate with cross-functional teams to ensure trials are completed on time, within budget, and in compliance with GCP and FDA regulations.

Requirements

• BS or MS degree with minimum 5 years clinical operations experience in pharmaceutical or biotech industry
• Direct experience managing early-stage clinical trials in an industry environment
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs
• Experience in selection and management of CROs/vendors and external resources
• Excellent written and verbal communication skills; thrives in a collaborative team setting

Responsibilities

• Manage clinical studies and vendors to ensure completion on time, within budget, and in compliance with SOPs, FDA, and ICH/GCP
• Oversee CRO activities, including selection, engagement, and management of CROs and other clinical study providers
• Develop and review study documentation: protocols, case report forms, informed consent forms, study manuals, and clinical database
• Prepare and track study participant enrollment projections and budgets; manage investigational product accountability and reconciliation
• Conduct site visits (training, initiation, monitoring) and serve as primary clinical operations contact for internal and external teams