Clinical Project Manager II – Early Phase Virology ​/Healthy Volunteer Studies (Sponsor Dedicate

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

Updated: Yesterday
Location: Morrisville, NC, United States
Job :-OTHLOC-1500-2

DMI-2DR

• Lead and manage Early Phase Healthy Volunteer clinical trials from study start‑up through closeout with minimal supervision.
• Drive day‑to‑day operational execution, study timelines, deliverables, and overall study performance.
• Serve as the primary operational point of contact for study sites.
• Lead operational activities across the full study lifecycle, including protocol development, study start‑up, study conduct, database lock, and CSR completion.
• Oversee dose‑escalation activities and support safety review processes required for Healthy Volunteer studies.
• Lead cross‑functional collaboration with Clinical Pharmacology, Biomarkers, Biostatistics, Statistical Programming, Medical Monitoring, Data Management, and other key stakeholders.
• Manage vendor relationships and monitor operational performance to support successful study execution.
• Facilitate study team meetings, document key decisions, and drive accountability for action items.
• Identify operational risks, develop mitigation strategies, and proactively resolve issues impacting study delivery.
• Maintain oversight of study documentation, trial metrics, and operational deliverables.
• Ensure studies are conducted in compliance with GCP, SOPs, regulatory requirements, and sponsor expectations.
• Contribute to process improvements and operational best practices that enhance study execution.

• Significant Clinical Project Management experience with responsibility for independently managing clinical trials across the full study lifecycle.
• Demonstrated experience leading Phase I and/or other early‑phase clinical studies.
• Recent, hands‑on experience managing the day‑to‑day operational delivery of Early Phase Healthy Volunteer clinical trials.
• Experience managing studies across the full study lifecycle, including protocol development, study start‑up, study conduct, and CSR completion.
• Experience leading day‑to‑day cross‑functional collaboration with Clinical Pharmacology, Biomarkers, Biostatistics, Statistical Programming, Medical Monitoring, Data Management, and related functions.
• Experience serving as the primary operational point of contact for study sites.
• Direct experience with study start‑up activities, dose‑escalation activities, safety review processes, and Healthy Volunteer study execution.
• Proven ability to work independently with minimal ramp‑up in a lean team environment.
• Strong project management, organizational, and operational leadership skills.
• Excellent verbal and written communication skills.
• Demonstrated ability to identify risks, solve problems, and drive study execution with minimal supervision.

• Virology clinical trial experience.
• Experience managing global Early Phase clinical trials within pharmaceutical, biotechnology, or CRO environments.
• Experience working within sponsor‑dedicated or embedded sponsor models.
• Experience managing multiple vendors and cross‑functional partnerships.
• Demonstrated success in collaborative, fast‑paced, execution‑focused environments.

• Has recently led the day‑to‑day operational execution of Early Phase Healthy Volunteer studies.
• Can independently drive study delivery with limited oversight.
• Understands the operational requirements of dose escalation and safety review activities through direct experience.
• Builds effective working relationships across study teams, sites, vendors, and functional stakeholders.
• Balances strategic planning with hands‑on operational execution.
• Demonstrates accountability, sound judgment, and a proactive approach to problem solving.
• Thrives in a lean, collaborative environment where adaptability and ownership are essential.

This role requires recent, hands‑on Early Phase Healthy Volunteer clinical trial experience. Candidates whose recent experience has been primarily focused on Phase II/III patient studies or project oversight roles where operational execution was managed by broader study teams may be less…