Clinical Project Manager II – Early Phase Oncology

Role Overview

• Drive operational execution of Early Phase Oncology clinical trials from study start-up through database lock and closeout
• Independently manage day-to-day study operations with minimal oversight
• Own timelines, deliverables, risks, and issue resolution across multiple workstreams
• Maintain deep operational awareness across all aspects of the trial — this is a role for someone comfortable working "in the weeds"
• Ensure study milestones stay on track in a fast-paced environment with shifting priorities and competing demands
• Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly
• Support operational activities associated with dose escalation cohorts, dose expansion cohorts, safety review meetings, protocol amendments, enrollment management, and study execution activities
• Monitor enrollment, site performance, data quality, and operational metrics to support successful study execution
• Drive accountability across study teams to ensure timelines and deliverables are met
• Lead vendor management activities and maintain strong oversight of external partners and CROs
• Contribute to RFP development, vendor selection, and ongoing vendor performance management
• Hold vendors accountable to timelines, deliverables, quality expectations, and issue resolution
• Actively manage operational follow-through rather than relying solely on escalation pathways
• Partner closely with CROs, monitoring teams, central laboratories, imaging vendors, and specialty oncology service providers
• Lead cross-functional meetings with clear agendas, action-oriented discussions, and strong follow-up
• Drive accountability across internal teams and external partners
• Build strong collaborative relationships while effectively navigating challenging conversations and competing priorities
• Mentor or support junior team members as needed
• Operate confidently within a matrixed global environment with multiple stakeholders
• Draft, review, and coordinate key study documents including protocols, informed consents, monitoring plans, investigator brochures, clinical study reports, and other essential study documentation
• Support study budget tracking, forecasting, and operational planning activities
• Review data listings and support interim and final reporting activities
• Train CROs, investigators, study coordinators, and vendors on protocol and study requirements
• Support inspection readiness activities and maintain compliance with GCP, ICH, and applicable regulatory requirements
• Contribute to SOP development, process improvement initiatives, and operational best practices

Requirements

• 3+ years of Clinical Project Management experience within clinical research
• Experience independently managing clinical trials from study start-up through closeout
• Direct Oncology clinical trial experience
• Direct Early Phase Oncology clinical trial experience supporting Phase I, Phase Ib, and/or Phase II studies
• Strong understanding of the unique operational requirements associated with Early Phase Oncology programs
• Experience supporting dose escalation and/or dose expansion studies
• Strong CRO/vendor management and oversight experience
• Proven ability to independently drive study execution in fast-paced clinical environments
• Experience managing cross-functional clinical trial activities within matrixed organizations
• Comfortable balancing strategic oversight with hands-on operational execution

Tech Stack

• Google Cloud Platform

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time