Experienced Clinical Project Manager - Inflammation (Sponsor Dedicated/ Remote- US only)

About the Role

We are seeking an experienced Clinical Project Manager to lead a complex Phase 2b inflammation program in a fast-paced, sponsor-dedicated, remote environment (U.S. only). This highly visible role requires strong operational leadership, accountability, and hands-on execution from study start-up through closeout. The ideal candidate thrives in high-accountability settings, balances strategic oversight with tactical involvement, and enjoys driving clinical trial execution in collaboration with cross-functional teams.

Why This Opportunity

• High-impact role supporting a complex Phase 2b inflammation study
• Opportunity to lead regional execution within a large global clinical program
• Strong visibility across Clinical Operations, leadership, and external partners
• Fast-moving environment with quick decision-making and execution
• Significant ownership and autonomy to independently drive study progress
• Collaborative sponsor-dedicated culture with supportive leadership
• Hands-on work alongside highly experienced clinical operations professionals

Responsibilities

End-to-End Clinical Trial Execution

• Drive operational execution of a complex Phase 2b inflammation study from 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
• Ensure study milestones stay on track in a fast-paced environment with shifting priorities
• Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions

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

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 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, and clinical study reports
• Support study budget tracking, forecasting, and operational planning activities
• Review data listings and support interim/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

Requirements

• 3+ years of clinical project management experience within clinical research
• 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 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

Key Strengths

• Highly organized with exceptional follow-through and attention to operational detail
• Comfortable working in the weeds while 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 working knowledge of Microsoft Word, Excel, and PowerPoint
• Ability to interpret and explain protocol requirements, operational processes, and study expectations to teams and stakeholders

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

Benefits

• Company car or car allowance
• Health benefits (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 (eligibility may vary by location)

Pay

The base salary range represents the anticipated low and high range for this position. Actual salary will vary based on candidate qualifications, skills, competencies, and proficiency for the role.