Clinical Project Manager II – Virology /Phase I (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA)

Job Responsibilities

Lead and manage global Phase I virology clinical trials from study start-up through closeout with minimal supervision
Drive overall study execution, timelines, deliverables, risks, budgets, and operational performance
Oversight and accountability for CROs, vendors, and cross-functional partners to ensure high-quality study execution
Build strong collaborative relationships with Clinical Operations, Data Management, Regulatory, Medical, Clinical Supply, Biometrics, and other stakeholders
Lead study team meetings by establishing clear agendas, facilitating productive discussions, documenting key decisions, and ensuring timely completion of action items
Proactively identify operational risks, develop mitigation strategies, and drive issue resolution before timelines or quality are impacted
Guide study teams through key transitions across the clinical trial lifecycle while ensuring seamless operational execution
Maintain oversight of study documentation, trial metrics, operational deliverables, and inspection readiness activities
Ensure compliance with GCP, SOPs, regulatory requirements, and sponsor expectations
Foster accountability across study teams while creating an environment of collaboration, transparency, and shared ownership
Contribute to process improvements and operational best practices that enhance study execution and team performance

Required Qualifications

• Bachelor's degree in a scientific or healthcare-related field (or equivalent combination of education and experience)
• Significant Clinical Project Management experience with responsibility for independently managing clinical trials across the full study lifecycle (5+ years)
• Demonstrated experience leading Phase I and/or other early-phase clinical studies
• Strong understanding of the complete clinical trial lifecycle, with the ability to independently manage study transitions from start-up through closeout
• Proven experience overseeing CROs, vendors, and external partners within global clinical trials
• Excellent project management, organizational, and operational leadership skills
• Strong meeting facilitation skills with the ability to lead productive discussions, build alignment, and ensure accountability for follow-up actions
• Exceptional verbal and written communication skills with demonstrated emotional intelligence and professionalism when working across diverse stakeholder groups
• Ability to lead cross-functional teams while effectively balancing multiple priorities in a fast-paced environment
• Demonstrated ability to proactively identify risks, solve problems independently, and drive successful study execution with minimal direction

Preferred Qualifications

• Virology clinical trial experience strongly preferred
• Experience managing global Phase I clinical trials within pharmaceutical, biotechnology, or CRO environments
• Stable career progression demonstrating increasing responsibility and leadership in clinical project management
• Experience working within sponsor-dedicated or embedded sponsor models
• Experience managing multiple vendors and complex cross-functional partnerships
• Demonstrated success working in highly collaborative, fast-paced, execution-focused environments