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: Remote, DC, United States Job ID: 25109963-OTHLOC-1500-2DDC-2DR Description Clinical Project Manager II – Early Phase Virology /Healthy Volunteer Studies (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 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. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health. 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. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. 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 to 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 ContributionRoles 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 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, creation, and bringing a dedicated and highly motivated senior individual to the health sciences team with: 1. agility; 2. ability to navigate the complex healthcare marketplace, and 3. the desire to work in a multidisciplinary discipline to accelerate the data‑driven businesses that drive confidence in timely respect and bafflement of investors. Discover what our more than 29,000 employees already know: we work hard, and smart, all in the name of getting much‑needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: #J-18808-Ljbffr Syneos Health, Inc.