Clinical Project Manager II – Immunology
New
S
Syneos HealthClinical research
Remote – United States; fully remote, US-based opportunityFull-TimeMiddle
Salary120,000 - 135,000 USD per year
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Job Details
- Experience
- 3+ years of Clinical Project Management experience supporting global immunology clinical trials
- Required Skills
- Microsoft Office Suite
Requirements
- Bachelor's degree in a scientific, healthcare, or related field.
- 3+ years of Clinical Project Management experience supporting global immunology clinical trials.
- Experience managing studies across multiple countries and regions.
- Vendor management experience.
- Strong understanding of clinical trial operations and study lifecycle management.
- Experience supporting Phase I, Phase II, Phase III, and/or Phase IV immunology studies.
- Working knowledge of ICH-GCP guidelines and clinical research regulations.
- Proficiency with Microsoft Office Suite.
- Ability to work effectively within global, cross-functional matrix organizations.
- Direct clinical trial experience in one or more immunology indications.
- Preferred: experience independently leading global immunology studies and supporting complex, multi-regional Phase II and Phase III programs.
- Preferred: familiarity with CTMS, eTMF, IRT/RTSM, and clinical data review platforms.
Responsibilities
- Partner with Clinical Study Leads and cross-functional study teams on global immunology trials.
- Lead study management activities across startup, conduct, maintenance, and closeout.
- Manage study timelines, deliverables, risks, and issue resolution.
- Oversee external vendors, CROs, central laboratories, specialty providers, and other study partners.
- Coordinate Clinical Team meetings and follow up on action items.
- Support study-level planning, forecasting, and operational strategy execution.
- Monitor study performance metrics and identify areas requiring intervention.
- Ensure inspection readiness and compliance with applicable regulations and sponsor requirements.
- Collaborate with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and Quality stakeholders.
- Contribute to study status reporting and executive-level communications; support milestones, enrollment targets, database locks, and study closeout activities.
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