Sponsor Dedicated Jobs (NOW HIRING)

Sponsor Dedicated | Remote (US)

Preference for Hybrid Foster City, CA-Based Candidates

Are you a Clinical Project Manager with recent, hands-on experience leading the operational execution of Early Phase Healthy Volunteer clinical trials from protocol development through Clinical Study Report (CSR)? Do you thrive in a lean environment where you are expected to independently drive study delivery, collaborate across functions, and maintain direct ownership of day-to-day study execution?

This opportunity supports innovative early-phase virology programs within a sponsor-dedicated environment. The team is seeking an experienced Clinical Project Manager who brings deep operational expertise in Healthy Volunteer studies and can confidently lead complex Phase I clinical trials from start-up through closeout.

Success in this role requires a highly organized, proactive individual who combines strong project leadership with hands-on operational execution. The ideal candidate has direct experience managing the day-to-day delivery of Early Phase Healthy Volunteer studies and can quickly contribute with minimal ramp-up.

This position is best suited for someone who has maintained operational ownership of studies throughout the clinical trial lifecycle and has extensive experience working directly with sites, vendors, and cross-functional stakeholders to drive study execution.

While remote candidates throughout the U.S. will be considered, preference will be given to candidates located in or near Foster City, California, with the ability to work onsite 2-3 days per week.

As a Clinical Project Manager II - Early Phase Virology, you will lead the operational execution of global Early Phase Healthy Volunteer studies while serving as the primary driver of study delivery across the clinical trial lifecycle.

You will oversee timelines, budgets, operational risks, study start-up activities, vendor performance, and cross-functional collaboration while ensuring studies are conducted in accordance with sponsor expectations and applicable quality requirements.

This role requires an individual who can independently navigate the complexities of early-phase clinical development, work effectively within a lean team structure, and maintain direct involvement in study operations from protocol development through CSR completion.

• 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 Clinical Study Report (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.

The ideal candidate:

• 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 aligned with the requirements of this position.

• Lead Early Phase virology studies with direct operational responsibility and visibility.

• Join a collaborative, execution-focused team environment.

• Maintain meaningful involvement in study operations across the entire study lifecycle.

• Partner closely with cross-functional stakeholders supporting early clinical development.

• Work in a role that values accountability, operational excellence, and independent leadership.

• Enjoy the flexibility of a remote work environment while maintaining close collaboration with sponsor leadership and study teams.

• Opportunity for experienced Clinical Project Managers to apply their Early Phase Healthy Volunteer expertise in a sponsor-dedicated setting.