Associate Director, Clinical Operations — Oncology Trials Lead

Alterome Therapeutics, Inc.; San Diego (CA); Hybrid; USD 200,000 - 250,000; Full time

Job summary

Alterome Therapeutics, Inc. is seeking an experienced Clinical Trial Manager to provide trial operational oversight of CROs and vendors for studies within the U.S. and abroad.

You will ensure GCP/SOP and protocol compliance and build strong vendor/site relationships, advancing the KRAS program at the forefront of oncology research. This role requires collaboration across cross-functional teams in a matrixed environment, managing start-up, enrollment, monitoring, and data metrics with a high

Qualifications

• Ten years of clinical research experience with sponsor-side roles
• Direct site management (monitoring) and study management across trials
• Phase I oncology dose escalation experience
• Prior Clinical Trial Manager experience
• Prior CRA or Site Study Coordinator experience
• Strong knowledge of ICH GCP and global guidelines
• Judgment to operate independently across protocols and sites
• Ability to work in a matrixed, diverse environment
• High sense of urgency and accountability

Responsibilities

• Oversee trial progress, including drug safety and patient safety tracking and protocol deviations
• Drive site readiness, start-up, enrollment, monitoring activities, and data metrics from CROs and vendors
• Provide day-to-day vendor oversight (CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) for budget, timelines, and program objectives
• Perform periodic reviews of CRO eTMF/TMF for regulatory compliance
• Timely review of CRO monitoring reports and deliverables to ensure sponsor oversight
• Support study financial management, including review of site and vendor invoices
• Maintain direct relationships with clinical sites for high-quality trial execution
• Identify risks proactively and propose mitigation to cross-functional teams
• Share study knowledge and training to improve practices and procedures

Skills

Clinical trial management

Sponsor-side experience

Phase I oncology dose escalation

Independent judgment

Matrixed environment collaboration

GCP knowledge

Site monitoring

Vendor oversight

Risk identification & mitigation

Education

BA/BS in a scientific or healthcare field

Tools

ICH GCP guidelines

Job description

Alterome Therapeutics, Inc. is seeking an experienced Clinical Trial Manager to provide trial operational oversight of CROs and vendors for studies within the U.S. and abroad.

You will ensure GCP/SOP and protocol compliance and build strong vendor/site relationships, advancing the KRAS program at the forefront of oncology research. This role requires collaboration across cross-functional teams in a matrixed environment, managing start-up, enrollment, monitoring, and data metrics with a high