Clinical Project Manager II - Virology/Phase ; Sponsor Dedicated - US Remote; Preference
La Crosse, La Crosse County, Wisconsin, 54602, USA
Listed on 2026-07-13
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Management
Regulatory Compliance Specialist
Clinical Project Manager II - Virology / Phase I (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA)
Are you a Clinical Project Manager who can independently lead global Phase I clinical trials from study start-up through closeout while remaining deeply engaged in the operational execution that drives successful early-phase development?
This is an opportunity to join a highly collaborative, fast-paced clinical operations team supporting innovative Phase I virology programs within a sponsor-dedicated environment. The team is seeking an experienced clinical project manager who thrives in early development, demonstrates exceptional operational leadership, and can confidently guide cross‑functional teams through the unique complexities of first‑in‑human and early‑phase studies.
Success in this role requires someone who is highly organized, proactive, and comfortable balancing strategic oversight with hands‑on execution. You should enjoy solving operational challenges, leading productive meetings, partnering closely with vendors and cross‑functional stakeholders, and proactively driving studies forward with minimal supervision.
This is not a role for someone who simply oversees study activities from a high level. The ideal candidate understands every phase of the clinical trial lifecycle because they have personally managed studies end‑to‑end and know how to anticipate issues before they impact timelines, quality, or deliverables.
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
- Provide 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
- 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
- Virology clinical trial…
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