Associate Clinical Trial Manager

📋 Description

• Manage or assist global oncology trials (Phase 1-3) per protocol and ICH-GCP.
• Track trial progress and status updates (site selection, enrollment, SDV, approvals).
• Maintain eTMF structure and index documents per ICH-GCP and SOPs.
• Oversee CRO TMF activities and QA TMF documents.
• Provide updates and action plans to project teams to resolve issues.
• Support regulatory inspections and audits (document retrieval, audit trails).

🎯 Requirements

• Undergraduate degree in Biological Sciences or related field.
• 1-2 years clinical operations experience in US and non-US trials (Phases 1-3).
• 1-2 years TMF/document management or clinical trial support.
• Experience with eTMF systems (Trial Interactive, Veeva Vault).
• Strong knowledge of ICH-GCP and US/foreign regulations.
• Ability to work with global, multi-disciplinary teams; self-starter; strong communication.

🎁 Benefits

• Paid time off, holidays, and sick leave.
• Medical, dental, and vision plans.
• Short- and long-term disability coverage.
• Life/AD&D and Flexible Spending Accounts.
• 401(k) with Erasca contributions and stock purchase program.
• Employee Assistance Program.