Clinical Project Manager II - Early Phase Oncology (Sponsor Dedicated/ Remote - US) Preference for Hybrid Foster City, CA-Based Candidates

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

Sponsor Dedicated/ Remote - US based only

Preference for Hybrid Foster City, CA-Based Candidates

**Please Note This role requires direct Early Phase Oncology clinical trial experience. Candidates must have experience supporting Phase I, Phase Ib, and/or Phase II Oncology studies. This is a sponsor requirement. Candidates without relevant Early Phase Oncology experience will not be considered.**

Are you a clinical project management professional who knows how to take ownership of a study from start-up through closeout - not just oversee it from a distance, but truly drive execution day-to-day?

This is a highly visible opportunity supporting innovative Early Phase Oncology clinical trials within a fast-paced sponsor-dedicated environment where strong operational leadership, accountability, and execution matter. The ideal candidate is comfortable operating both strategically and tactically - someone who can lead cross-functional teams while also rolling up their sleeves and working in the details to keep studies moving forward.

We are specifically seeking candidates with hands-on experience supporting Early Phase Oncology clinical trials, including the unique operational complexities associated with dose escalation, dose expansion, safety review processes, protocol amendments, and early clinical development programs.

If you thrive in high-accountability environments, can navigate ambiguity, and enjoy being deeply involved in clinical trial execution from start to finish, this role offers the opportunity to make a direct impact.

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.

* High-impact role supporting innovative Early Phase Oncology clinical development programs

* Opportunity to contribute to studies evaluating potentially life-changing therapies for cancer patients

* Strong visibility across Clinical Operations, Medical, Biometrics, Safety, Regulatory, and external partners

* Fast-moving environment where decisions and execution happen quickly

* Significant ownership and autonomy with the expectation to independently drive study progress

* Collaborative sponsor-dedicated culture with supportive leadership and strong team partnership

* Opportunity to work alongside highly experienced oncology drug development professionals in a hands-on environment

End-to-End Clinical Trial Execution

* Drive operational execution of Early Phase Oncology clinical trials from study start-up through database lock and closeout

* Independently manage day-to-day study operations with minimal oversight

* Own timelines, deliverables, risks, and issue resolution across multiple workstreams

* Maintain deep operational awareness across all aspects of the trial - this is a role for someone comfortable working "in the weeds"

* Ensure study milestones stay on track in a fast-paced environment with shifting priorities and competing demands

* Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly

* Support operational activities associated with dose escalation cohorts, dose expansion cohorts, safety review meetings, protocol amendments, enrollment management, and study execution activities

* Monitor enrollment, site performance, data quality, and operational metrics to support successful study execution

* Drive accountability across study teams to ensure timelines and deliverables are met

Vendor & CRO Oversight

* Lead vendor management activities and maintain strong oversight of external partners and CROs

* Contribute to RFP development, vendor selection, and ongoing vendor performance management

* Hold vendors accountable to timelines, deliverables, quality expectations, and issue resolution

* Actively manage operational follow-through rather than relying solely on escalation pathways

* Partner closely with CROs, monitoring teams, central laboratories, imaging vendors, and specialty oncology service providers

Cross-Functional Leadership

* Lead cross-functional meetings with clear agendas, action-oriented discussions, and strong follow-up

* Drive accountability across internal teams and external partners

* Build strong collaborative relationships while effectively navigating challenging conversations and competing priorities

* Mentor or support junior team members as needed

* Operate confidently within a matrixed global environment with multiple stakeholders

Study Operations & Documentation

* Draft, review, and coordinate key study documents including protocols, informed consents, monitoring plans, investigator brochures, clinical study reports, and other essential study documentation

* Support study budget tracking, forecasting, and operational planning activities

* Review data listings and support interim and final reporting activities

* Train CROs, investigators, study coordinators, and vendors on protocol and study requirements

* Support inspection readiness activities and maintain compliance with GCP, ICH, and applicable regulatory requirements

* Contribute to SOP development, process improvement initiatives, and operational best practices

Required Experience

* 3+ years of Clinical Project Management experience within clinical research

* Experience independently managing clinical trials from study start-up through closeout

* Direct Oncology clinical trial experience

* Direct Early Phase Oncology clinical trial experience supporting Phase I, Phase Ib, and/or Phase II studies

* Strong understanding of the unique operational requirements associated with Early Phase Oncology programs

* Experience supporting dose escalation and/or dose expansion studies

* Strong CRO/vendor management and oversight experience

* Proven ability to independently drive study execution in fast-paced clinical environments

* Experience managing cross-functional clinical trial activities within matrixed organizations

* Comfortable balancing strategic oversight with hands-on operational execution

Highly Preferred Experience

* First-in-human (FIH) study experience

* Experience supporting solid tumor and/or hematologic malignancy programs

* Experience supporting global or multi-regional oncology studies

* Experience working within sponsor-dedicated, biotechnology, or pharmaceutical environments

* Experience supporting complex oncology protocols involving multiple cohorts or adaptive study designs

Key Strengths

* Highly organized with exceptional follow-through and attention to operational detail

* Comfortable working in the weeds while still maintaining a high-level program perspective

* Ability to prioritize effectively and pivot quickly in fast-moving environments

* Strong meeting leadership, communication, and stakeholder management skills

* Confident driving accountability across teams and vendors

* Solutions-oriented mindset with strong initiative and urgency

* High emotional intelligence and ability to navigate high-stakes conversations professionally

* Collaborative, transparent, and team-oriented approach

Technical & Regulatory Expertise

* Thorough knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements

* Strong understanding of operational considerations associated with Early Phase Oncology clinical trials

* Strong working knowledge of Microsoft Word, Excel, and PowerPoint

* Ability to interpret and explain protocol requirements, operational processes, and study expectations to teams and stakeholders

This team values collaboration, accountability, and execution. The environment is fast-paced, highly interactive, and best suited for individuals who enjoy being actively engaged in study operations rather than operating at a distance.

Leadership is approachable, mentorship-focused, and supportive, while still maintaining high expectations around ownership and delivery. The team works hard, communicates openly, and genuinely supports one another to keep studies moving forward successfully.

If you are looking for an opportunity where you can independently lead Early Phase Oncology clinical trials from start to finish, operate in a fast-paced environment, and play a hands-on role in execution and delivery, this is an excellent next step in your clinical operations career.

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.

http://www.syneoshealth.com

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.