Project Manager II - Inflammation/ Phase 2b (Sponsor-Dedicated /Remote -U.S.)

Syneos Health • USA-CA-Client, OH

1d • Remote

About The Position

Syneos Health is a leading fully-integrated life sciences services organization. This role is for a Project Manager II supporting a Sponsor-Dedicated, Remote (U.S.) position focused on an Inflammation/Phase 2b clinical trial. The company partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. The role offers opportunities within Functional Service Provider partnerships or Full-Service environments, collaborating with problem solvers to achieve customer goals. Syneos Health emphasizes career development, inclusivity, and a purpose-driven culture ('Driven to Deliver'). The company aims to shape the future of healthcare by bringing together diverse colleagues to drive impact for customers and patient progress.

Requirements

• 3+ years of clinical project management experience within clinical research.
• Experience supporting complex Phase 2b clinical studies within the inflammation therapeutic area.
• Strong vendor management and oversight experience.
• Demonstrated understanding of the full clinical trial lifecycle from start-up through closeout.
• Experience managing cross-functional clinical trial activities in a matrixed environment.
• Ability to independently manage priorities and navigate operational challenges with minimal supervision.
• Strong meeting leadership and communication skills.
• High emotional intelligence with the ability to communicate tactfully in high-stakes discussions.
• Confident leading cross-functional teams and driving accountability.
• Excellent organizational, decision-making, and problem-solving abilities.
• Positive, solutions-oriented mindset with strong initiative.
• Collaborative approach with a focus on transparency and teamwork.
• Thorough knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements.
• Strong working knowledge of Word, Excel, and PowerPoint.
• Ability to understand, interpret, and explain protocol requirements to study teams and stakeholders.

Responsibilities

• Manage regional components of a large, complex clinical trial within the inflammation therapeutic area.
• Independently drive study activities with minimal oversight.
• Lead cross-functional timelines and ensure alignment across stakeholders.
• Proactively identify operational risks, escalate issues appropriately, and implement solutions.
• Support study logistics and operational planning to achieve program milestones.
• Lead vendor management activities and maintain strong oversight of external partners.
• Contribute to RFP development and participate in CRO/service provider selection processes.
• Ensure accountability across vendors while maintaining productive working relationships.
• Support operational issue resolution and follow-through on deliverables.
• Lead meetings effectively by setting agendas, facilitating productive discussions, documenting decisions, and driving action items to completion.
• Partner across Clinical Operations and study teams to maintain executional excellence.
• Provide leadership and mentorship to junior team members when needed.
• Foster collaboration and accountability across internal and external stakeholders.
• Draft and coordinate review of key study documents including protocols, informed consents, monitoring plans, investigator brochures, and clinical study reports.
• Maintain study timelines and support study budget activities.
• Coordinate review of data listings and support interim/final clinical study reporting activities.
• Train CROs, investigators, study coordinators, and service providers on study requirements as needed.
• Contribute to SOP development, process improvement initiatives, and operational best practices.

Benefits

• 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
• Flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed