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

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

Remote (US) with preference for candidates who can work onsite 2-3 days per week in Foster City, CA.

• 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
• Experience leading global Phase II-III studies within CRO, biotech, or pharmaceutical environments
• Experience with in sponsor‑dedicated models or embedded sponsor teams
• Stable career progression demonstrating increasing operational ownership and leadership responsibilities
• Candidates should be prepared to discuss the depth and duration of their independent…