Clinical Project Manager II - Virology; Sponsor Dedicated - US Remote; Preference Hybrid Fo

Job Title & Location

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

As a Clinical Project Manager II – Virology, you will lead operational execution for global Phase II–III clinical trials and serve as a key driver of study delivery across the full clinical trial lifecycle. You will oversee timelines, vendors, risks, operational strategy, study maintenance activities, and cross‑functional coordination while ensuring studies remain inspection‑ready, operationally sound, and aligned with sponsor expectations.

• Lead and manage global Phase II–III clinical trials from study start‑up through database lock and closeout with minimal oversight
• Serve as the operational lead responsible for driving study execution, timelines, deliverables, risks, and overall trial performance
• Provide close oversight of CROs, regional leads, vendors, and study teams to ensure operational alignment, accountability, and execution quality
• Independently manage and support IRT/IXRS activities, including study setup oversight, ongoing maintenance, issue management, troubleshooting, and cross‑functional coordination
• Maintain direct involvement in day‑to‑day study operations, including reviewing monitoring reports, study documentation, operational deliverables, and site‑related activities
• Oversee site management and study maintenance activities to ensure studies remain inspection‑ready and operationally compliant
• Review and manage informed consent forms (ICFs), study documentation, and operational materials to support quality and compliance expectations
• Manage operational trackers, including 1572 trackers and other critical study maintenance trackers, ensuring accuracy, completeness, and timely follow‑up
• Drive study team meetings by developing agendas, facilitating discussions, documenting decisions, and ensuring accountability for action items
• Partner cross‑functionally with Clinical Operations, data management, regulatory, vendors, and other stakeholders to support seamless study execution
• Serve as a subject matter expert across study operations, helping resolve operational challenges and guide teams through complex issues
• Proactively identify operational risks, gaps, and delays before they impact study timelines, quality, or deliverables
• Navigate fast‑paced, high‑visibility environments with the ability to prioritize effectively and adapt quickly to changing business needs
• Ensure studies remain compliant with GCP, SOPs, regulatory requirements, and sponsor expectations
• Contribute to process improvement initiatives and operational best practices that enhance study execution and team effectiveness

• Strong hands‑on Clinical Operations experience with the ability to independently manage global Phase II–III clinical trials across the full study lifecycle
• Proven experience operating both strategically and tactically, including deep involvement in day‑to‑day study execution activities
• Direct experience overseeing CROs, regional leads, and vendor partnerships within global clinical trials
• Strong experience with IRT/IXRS systems, including hands‑on management, troubleshooting, maintenance, and operational oversight responsibilities
• Experience reviewing monitoring reports, study documentation, ICFs, and operational deliverables directly
• Experience managing operational trackers and study maintenance activities, including 1572 tracking and inspection readiness support
• Strong site management and study maintenance experience within complex global clinical trials
• Demonstrated ability to proactively identify operational risks, troubleshoot issues, and drive resolution independently
• Strong cross‑functional leadership and stakeholder management skills
• Excellent organizational, communication, meeting facilitation, and problem‑solving abilities
• Ability to thrive in fast‑paced clinical development environments with competing priorities and aggressive timelines
• Professional presence with strong emotional intelligence and the ability to build credibility quickly across teams

• Virology therapeutic area experience strongly preferred
• Experi…