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

Job Responsibilities

Clinical Project Manager II - Early Phase Virology (Healthy Volunteer Studies)

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.

THE ROLE

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.

WHAT YOU WILL DO

• 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.

WHO YOU ARE

Required Qualifications

• 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.

Preferred Qualifications

• 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.

WHO WILL BE SUCCESSFUL

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.

WHAT MAKES THIS OPPORTUNITY DIFFERENT

• 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.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:
$95,000.00 - $175,700.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.

Summary
Roles within Clinical Project Management job family at the M23 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. Responsibilities include site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. These roles also involve monitoring progress and following up with team members and line managers when issues develop. Additionally, they implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and Contribution Roles within Clinical Project Management job family at the M23 level significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By gathering input from cross-functional teams and creating detailed plans, these roles help ensure that deliverables are produced on schedule, contributing to the overall success of the clinical trials. Their oversight of operational aspects of clinical trials ensures consistency and adherence to SOP, GCP, and country regulations, which is crucial for the integrity and reliability of the study results. Additionally, their involvement in site and vendor selection, budget preparation, and monitoring progress helps maintain the smooth operation of clinical trials, ultimately contributing to the advancement of clinical research and development. Core Focus • Planning, directing, creating, and communicating clinical study timelines • Overseeing operational aspects of clinical trials • Ensuring consistency across clinical studies • Adhering to SOP, GCP, and country regulations • Selecting sites and vendors • Preparing clinical trial budgets • Monitoring progress and