Description
Clinical Project Manager II - Inflammation Sponsor-Dedicated | Remote (U.S.) Preference for Hybrid Foster City, CA-Based Candidates

Job Responsibilities

Clinical Project Manager II - Inflammation

Sponsor-Dedicated | Remote (U.S.) Preference for Hybrid Foster City, CA-Based Candidates

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 a complex Phase 2b inflammation program 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 a study moving forward.

As the regional lead, you will be expected to independently own and drive all operational aspects of your assigned region, proactively identifying risks, implementing solutions, and serving as a key partner in ensuring global study success. This role requires someone who can connect site-level activities to regional and study-wide objectives while maintaining strong oversight of CROs, sites, and operational performance.

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 to 3 days per week.

WHY THIS OPPORTUNITY

• High-impact role supporting a complex Phase 2b inflammation study
• Opportunity to lead regional execution efforts within a large global clinical program
• Strong visibility across Clinical Operations, leadership, and external partners
• Fast-moving environment where decisions and execution happen quickly
• Significant ownership and autonomy with the expectation to independently drive study progress and regional performance
• Collaborative sponsor-dedicated culture with supportive leadership and strong team partnership
• Opportunity to work alongside highly experienced clinical operations professionals in a hands-on environment

WHAT YOU WILL OWN

End-to-End Clinical Trial Execution

• Drive operational execution of a complex Phase 2b inflammation study from study start-up through database lock and closeout
• Serve as the regional clinical trial lead, independently managing your assigned region as a "study within the study"
• Own regional study operations including site start-up, enrollment, maintenance, and closeout activities
• Independently manage day-to-day study operations with minimal oversight while maintaining alignment with global study objectives
• Own timelines, deliverables, risks, and issue resolution across multiple workstreams
• Maintain deep operational awareness across all aspects of the trial and proactively connect site-level activities to regional and study-level objectives
• Ensure study milestones remain 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
• Ensure protocol compliance, inspection readiness, monitoring quality, and operational excellence across assigned sites and countries

Regional Leadership & Risk Management

• Provide end-to-end operational ownership and oversight for assigned geographic regions
• Proactively identify current and emerging risks, assess potential regional and study-level impacts, and drive mitigation strategies before issues escalate
• Evaluate site, enrollment, CRA, and operational trends to identify challenges early and implement effective solutions
• Connect site-level issues to broader regional and study-level risks and communicate impacts appropriately
• Present recommendations when escalating issues, including proposed options, rationale, and recommended path forward
• Partner closely with Clinical Project Management, Global CTMs, CRO teams, Clinical Development, Clinical Study Partners, and other stakeholders to resolve challenges and maintain study momentum
• Ensure local regulatory, affiliate, and country-specific requirements are understood and executed appropriately
• Operate independently with a high degree of ownership, accountability, and decision-making authority within assigned responsibilities

Vendor & CRO Oversight

• Lead vendor management activities and maintain strong oversight of external partners and CROs
• Provide direct oversight of CRO performance within assigned regions, ensuring alignment with study timelines, quality expectations, and operational plans
• Track regional deliverables, performance metrics, and issue resolution activities
• 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

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
• Communicate regional status, risks, mitigation plans, and critical decisions clearly and proactively to study leadership and cross-functional partners

Study Operations & Documentation

• Draft, review, and coordinate key study documents including protocols, informed consent forms, monitoring plans, investigator brochures, and clinical study reports
• 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
• Contribute to SOP development, process improvement initiatives, and operational best practices

WHAT YOU BRING

Required Experience

• 3+ years of clinical project management experience within clinical research
• Experience serving as a regional lead or managing a geographic region within global clinical trials
• Experience running clinical trials from start-up through closeout, with a strong understanding of the full clinical trial lifecycle
• Experience supporting complex Phase 2b studies within the inflammation therapeutic area
• Strong CRO/vendor management and oversight experience
• Proven ability to independently drive regional study execution in fast-paced clinical environments
• Experience managing cross-functional clinical trial activities within matrixed global organizations
• Demonstrated ability to proactively identify operational risks, develop mitigation strategies, and influence resolution across stakeholders
• Comfortable balancing strategic oversight with hands-on operational execution

Key Strengths

• Strong sense of ownership and accountability with the ability to independently manage a region end-to-end
• 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 connect site-level activities and issues to broader regional and global study impact
• Strong problem-solving skills with a proactive, solutions-oriented approach
• Ability to identify trends and risks early, recommend actionable solutions, and drive outcomes
• 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 working knowledge of Microsoft Word, Excel, and PowerPoint
• Ability to interpret and explain protocol requirements, operational processes, and study expectations to teams and stakeholders
• Understanding of regional regulatory requirements and country-level operational considerations within global clinical trials

TEAM CULTURE

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.

Successful team members demonstrate a strong sense of ownership, proactively identify and solve problems, communicate clearly, and independently drive their areas of responsibility forward. Regional leads are trusted to manage their region with minimal direction, anticipate challenges before they escalate, and translate operational details into meaningful study-level insights and actions.

Leadership is approachable, mentorship-focused, and supportive, while still maintaining high expectations around ownership, accountability, 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 a complex clinical trial from start to finish, own regional execution end-to-end, 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:
$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.