Clinical Project Manager II - Virology (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA)

Clinical Project Manager II - Virology (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 – Virology

Sponsor Dedicated | Remote (US)

(Preference for Hybrid Foster City, CA-Based Candidates)

Are you a Clinical Project Manager who can independently drive global Phase II–III clinical trials from start-up through closeout — while also staying deeply engaged in the operational details that keep studies running successfully day to day?

This is an opportunity to join a highly collaborative, fast-paced clinical operations team supporting innovative virology programs within a sponsor-dedicated environment. The team is specifically seeking a hands-on operational leader — someone who is comfortable rolling up their sleeves, navigating complex study execution challenges directly, and operating far beyond high-level oversight alone.

The ideal candidate is someone who genuinely enjoys being “in the weeds” operationally. You should be comfortable actively reviewing study documentation, managing operational trackers, troubleshooting systems and processes, partnering closely with CROs and regional leads, and driving execution across all facets of study operations.

This is not a purely strategic oversight role. The team is looking for someone who understands what strong operational execution looks like because they have personally done the work themselves.

While virology experience is strongly preferred, candidates with strong global Phase II–III clinical trial management experience in other therapeutic areas will also be considered.

This team values operational excellence, accountability, collaboration, urgency, adaptability, and proactive problem-solving. Leadership is highly supportive, mentorship-focused, and invested in helping strong performers expand their impact and career trajectory.

While remote/home-based candidates may be considered, priority 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 – Virology, you will lead operational execution for global Phase II–III clinical trials and serve as a key driver of study delivery across the full clinical trial lifecycle.

You will oversee timelines, vendors, risks, operational strategy, study maintenance activities, and cross-functional coordination while ensuring studies remain inspection-ready, operationally sound, and aligned with sponsor expectations.

Success in this role requires someone who can confidently balance strategic leadership with hands-on operational execution. You must be comfortable working directly within study details, identifying gaps proactively, troubleshooting operational issues in real time, and driving studies forward with urgency and accountability.

You will partner closely with Clinical Operations, CROs, regional leads, vendors, and cross-functional stakeholders in a highly visible environment where strong execution, adaptability, and operational ownership are critical.

WHAT YOU WILL DO

• Lead and manage global Phase II–III clinical trials from study start-up through database lock and closeout with minimal oversight

• Serve as the operational lead responsible for driving study execution, timelines, deliverables, risks, and overall trial performance

• Provide close oversight of CROs, regional leads, vendors, and study teams to ensure operational alignment, accountability, and execution quality

• Independently manage and support IRT/IXRS activities, including study setup oversight, ongoing maintenance, issue management, troubleshooting, and cross-functional coordination

• Maintain direct involvement in day-to-day study operations, including reviewing monitoring reports, study documentation, operational deliverables, and site-related activities

• Oversee site management and study maintenance activities to ensure studies remain inspection-ready and operationally compliant

• Review and manage informed consent forms (ICFs), study documentation, and operational materials to support quality and compliance expectations

• Manage operational trackers, including 1572 trackers and other critical study maintenance trackers, ensuring accuracy, completeness, and timely follow-up

• Drive study team meetings by developing agendas, facilitating discussions, documenting decisions, and ensuring accountability for action items

• Partner cross-functionally with Clinical Operations, data management, regulatory, vendors, and other stakeholders to support seamless study execution

• Serve as a subject matter expert across study operations, helping resolve operational challenges and guide teams through complex issues

• Proactively identify operational risks, gaps, and delays before they impact study timelines, quality, or deliverables

• Navigate fast-paced, high-visibility environments with the ability to prioritize effectively and adapt quickly to changing business needs

• Ensure studies remain compliant with GCP, SOPs, regulatory requirements, and sponsor expectations

• Contribute to process improvement initiatives and operational best practices that enhance study execution and team effectiveness

WHO YOU ARE

Required Qualifications

• Strong hands-on Clinical Operations experience with the ability to independently manage global Phase II–III clinical trials across the full study lifecycle

• Proven experience operating both strategically and tactically, including deep involvement in day-to-day study execution activities

• Direct experience overseeing CROs, regional leads, and vendor partnerships within global clinical trials

• Strong experience with IRT/IXRS systems, including hands-on management, troubleshooting, maintenance, and operational oversight responsibilities

• Experience reviewing monitoring reports, study documentation, ICFs, and operational deliverables directly

• Experience managing operational trackers and study maintenance activities, including 1572 tracking and inspection readiness support

• Strong site management and study maintenance experience within complex global clinical trials

• Demonstrated ability to proactively identify operational risks, troubleshoot issues, and drive resolution independently

• Strong cross-functional leadership and stakeholder management skills

• Excellent organizational, communication, meeting facilitation, and problem-solving abilities

• Ability to thrive in fast-paced clinical development environments with competing priorities and aggressive timelines

• Professional presence with strong emotional intelligence and the ability to build credibility quickly across teams

Preferred Experience

• Virology therapeutic area experience strongly preferred

• Experience leading global Phase II–III studies within CRO, biotech, or pharmaceutical environments

• Experience within sponsor-dedicated models or embedded sponsor teams

• Stable career progression demonstrating increasing operational ownership and leadership responsibilities

• Candidates should be prepared to discuss the depth and duration of their independent IRT/IXRS management experience during the interview process

• Ability to lead confidently in highly collaborative, fast-moving, and high-accountability environments

WHAT MAKES THIS OPPORTUNITY DIFFERENT

• Opportunity to lead and drive global clinical trials end-to-end in a highly visible role with meaningful operational impact

• Join a leadership team that values mentorship, collaboration, accountability, and continuous growth

• Work alongside experienced clinical operations professionals who are highly engaged, supportive, and execution-focused

• Gain exposure to innovative virology programs within a respected sponsor-dedicated environment

• Play a highly hands-on role where your operational expertise and ability to execute will directly influence study success

• Be empowered to contribute ideas, improve processes, and solve real operational challenges rather than simply providing high-level oversight

• Thrive in a fast-paced environment that values urgency, ownership, operational excellence, and proactive problem-solving

• Flexibility of a remote environment combined with close partnership and engagement from leadership and study teams

• Excellent opportunity for high-performing Clinical Project Managers seeking broader ownership, visibility, and continued career growth within clinical operations

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:

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, 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 following up with team members and line managers • Implementing and preparing the clinical development strategy • Developing trial recruitment strategies