Are you passionate about advancing innovative therapies for patients living with autoimmune and inflammatory diseases? We are seeking experienced Clinical Project Managers with strong global immunology clinical trial experience to join a high-performing sponsor-dedicated team supporting a diverse portfolio of immunology studies across multiple indications and phases of development.This is a fully remote, US-based opportunity where you will play a critical role in the operational leadership and execution of global clinical trials. We are specifically seeking professionals with 3+ years of hands-on Clinical Project Management experience leading global immunology studies and collaborating with cross-functional teams, vendors, and international stakeholders.WHAT YOU'LL DOAs a Clinical Project Manager II, you will help drive the operational execution and delivery of global immunology clinical trials, ensuring studies are conducted efficiently, compliantly, and according to established timelines.Key ResponsibilitiesSupport and partner with Clinical Study Leads and cross-functional study teams on global immunology trialsLead day-to-day study management activities across study startup, conduct, maintenance, and closeoutManage study timelines, deliverables, risks, and issue resolutionOversee external vendors, CROs, central laboratories, specialty providers, and other study partnersCoordinate Clinical Team meetings and drive action item follow-upSupport study-level planning, forecasting, and operational strategy executionMonitor study performance metrics and proactively identify areas requiring interventionEnsure inspection readiness and compliance with applicable regulations and sponsor requirementsCollaborate with stakeholders across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and QualityContribute to study status reporting and executive-level communicationsSupport achievement of study milestones, enrollment targets, database locks, and study closeout activitiesWHAT YOU WILL BRINGRequired QualificationsBachelor's degree in a scientific, healthcare, or related field3+ years of Clinical Project Management experience supporting global immunology clinical trialsExperience managing studies across multiple countries and regions (North America, Europe, Asia-Pacific, Lat other global regions)Vendor management experience requiredStrong understanding of clinical trial operations and study lifecycle managementExperience supporting Phase I, Phase II, Phase III, and/or Phase IV immunology studiesStrong working knowledge of ICH-GCP guidelines and clinical research regulationsProficiency with Microsoft Office SuiteAbility to work effectively withss-functional matrix organizationsIMMUNOLOGY THERAPEUTIC AREA EXPERIENCECandidates should have direct clinical trial experience supporting one or more immunology indications, including but not limited to:Gastroenterology / Inflammatory Bowel Disease (IBD): Ulcerative Colitis (UC); Crohn's Disease (CD)Autoimmune and Inflammatory Diseases: Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA); Ankylosing Spondylitis (AS); Axial Spondyloarthritis (axSpA); Systemic Lupus Erythematosus (SLE); Sjögren's Syndrome; Vasculitis; Other Autoimmune DisordersDermatology: Plaque Psoriasis; Atopic Dermatitis (Eczema); Hidradenitis Suppurativa; Vitiligo; Other Immune-Mediated Dermatologic DiseasesRespiratory and Allergy: Severe Asthma; Eosinophilic Disorders; Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); Allergic and Inflammatory Respiratory DiseasesOther Immune-Mediated Disorders: Rare Immunologic Diseases; Immune-Mediated Inflammatory Disorders (IMIDs); Emerging Immunology IndicationsCandidates should be prepared to discuss the indications supported, study phases, geographic scope, and their specific responsibilities on each program.PREFERRED QUALIFICATIONSExperience independently leading global immunology studiesExperience supporting complex, multi-regional Phase II and Phase III programsExperience with early-phase immunology studies (Phase I/Ib)Experience supporting biologics, monoclonal antibodies, immunomodulators, or novel immune-targeted therapiesFamiliarity with CTMS, eTMF, IRT/RTSM, and clinical data review platformsExperience working in sponsor-dedicated or FSP environmentsKEY SKILLS & COMPETENCIESStrong project management and organizational skillsExcellent communication and stakeholder management abilitiesProven ability to manage multiple priorities in a fast-paced environmentStrong risk identification and mitigation capabilitiesDetail-oriented with a focus on quality, compliance, and executionStrong collaboration skills across global teams and functionsAbility to influence without direct authority and drive accountability across study teamsCLINICAL PHASE EXPERIENCEWe welcome candidates with experience supporting:Phase I / First-in-Human StudiesPhase I/Ib Dose Escalation StudiesPhase II Proof-of-Concept StudiesPhase II/III Registrational StudiesPhase III Global Pivotal TrialsPhase IV and Post-Marketing StudiesExperience supporting global, multi-country immunology programs through multiple phases of development is highly preferred.WHY JOIN US?Work on innovative immunology programs advancing new treatment options for patients with autoimmune and inflammatory diseasesSupport cutting-edge therapies across inflammatory bowel disease, dermatology, rheumatology, respiratory, and other immune-mediated disordersJoin a collaborative, sponsor-dedicated team focused on operational excellenceEnjoy the flexibility of a fully remote US-based roleExpand your impact across global clinical development programs and contribute to bringing life-changing therapies to patientsIf you are an experienced Immunology Clinical Project Manager with 3+ years of global clinical trial management experience and a passion for advancing therapies for autoimmune and inflammatory diseases, we would love to hear from you.Salary Range: $120,000–$135,000At Syneos Health, we believe elop 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 gibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certagibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.Get to know Syneos HealthOver 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.Additional InformationTasks, 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. 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 hereluding 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.
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