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About the Role

Manage the day-to-day operational execution of global clinical trials from study start-up through closeout, coordinating study activities, managing timelines and vendors, and monitoring study and site performance.

Responsibilities

• Manage day-to-day global clinical trial activities from study start-up through conduct and closeout, including timelines, milestones, enrollment, and study performance.
• Support protocol review, feasibility assessments, site selection and activation, and protocol amendment activities.
• Manage CROs, sites, and clinical vendors, including oversight of plans, deliverables, timelines, budgets, and quality.
• Oversee monitoring activities, including monitoring report review, U.S. co-monitoring, site performance, protocol deviations, data queries, and follow-up of significant issues.
• Identify operational risks and work cross-functionally to develop and implement mitigation strategies.
• Lead study team meetings and communicate study progress, risks, decisions, and action items to internal and external stakeholders.
• Ensure study conduct and TMF quality are consistent with study protocols, ICH/GCP, applicable regulatory requirements, and inspection-readiness expectations.

Requirements

• Clinical operations experience in biotechnology, pharmaceutical, or CRO environments.
• Strong project management, communication, problem-solving, and organizational skills.
• Proficiency with EDC, IRT, CTMS, and eTMF.
• Ability to work effectively in a small, fast-paced biotech environment.

Skills

• ADC clinical trial experience
• Project management
• Communication
• Problem-solving
• Organizational skills
• EDC
• IRT
• CTMS
• eTMF

Location

• San Francisco Bay Area
• South San Francisco

Work Type

• Contract
• Hybrid
• Full-time

Experience Level

• 6 to 12-month contract assignment

Salary/Compensations

• $70 per hour

About the Company

• ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives.
• ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built.
• Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications.
• ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action.
• A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors.