CLINICAL PROJECT MANAGER II - IMMUNOLOGY (Sponsor Dedicated/ Remote- US)

CLINICAL PROJECT MANAGER II - IMMUNOLOGY (Sponsor Dedicated/ Remote- US) Updated: Yesterday Location: Remote, NC, United States Job ID: 25108968 Description CLINICAL PROJECT MANAGER II - IMMUNOLOGY (Sponsor Dedicated/ Remote- US) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong. Job Responsibilities

CLINICAL PROJECT MANAGER II - IMMUNOLOGY

Sponsor Dedicated | Remote - United States 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 DO

As 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 Responsibilities Support and partner with Clinical Study Leads and cross-functional study teams on global immunology trials Lead day-to-day study management activities across study 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 drive action item follow-up Support study-level planning, forecasting, and operational strategy execution Monitor study performance metrics and proactively identify areas requiring intervention Ensure inspection readiness and compliance with applicable regulations and sponsor requirements Collaborate with stakeholders across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and Quality Contribute to study status reporting and executive-level communications Support achievement of study milestones, enrollment targets, database locks, and study closeout activities

WHAT YOU WILL BRING

Required Qualifications 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 (North America, Europe, Asia-Pacific, Latin America, or other global regions) Vendor management experience required Strong understanding of clinical trial operations and study lifecycle management Experience supporting Phase I, Phase II, Phase III, and/or Phase IV immunology studies Strong 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

IMMUNOLOGY THERAPEUTIC AREA EXPERIENCE

Candidates 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 Disorders Dermatology Plaque Psoriasis Atopic Dermatitis (Eczema) Hidradenitis Suppurativa Vitiligo Other Immune-Mediated Dermatologic Diseases Respiratory and Allergy Severe Asthma Eosinophilic Disorders Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Allergic and Inflammatory Respiratory Diseases Other Immune-Mediated Disorders Rare Immunologic Diseases Immune-Mediated Inflammatory Disorders (IMIDs) Emerging Immunology Indications Candidates should be prepared to discuss the indications supported, study phases, geographic scope, and their specific responsibilities on each program.

PREFERRED QUALIFICATIONS

Experience independently leading global immunology studies Experience supporting complex, multi-regional Phase II and Phase III programs Experience with early-phase immunology studies (Phase I/Ib) Experience supporting biologics, monoclonal antibodies, immunomodulators, or novel immune-targeted therapies Familiarity with CTMS, eTMF, IRT/RTSM, and clinical data review platforms Experience working in sponsor-dedicated or FSP environments

KEY SKILLS & COMPETENCIES

Strong project management and organizational skills Excellent communication and stakeholder management abilities Proven ability to manage multiple priorities in a fast-paced environment Strong risk identification and mitigation capabilities Detail-oriented with a focus on quality, compliance, and execution Strong collaboration skills across global teams and functions Ability to influence without direct authority and drive accountability across study teams

CLINICAL PHASE EXPERIENCE

We welcome candidates with experience supporting: Phase I / First-in-Human Studies Phase I/Ib Dose Escalation Studies Phase II Proof-of-Concept Studies Phase II/III Registrational Studies Phase III Global Pivotal Trials Phase IV and Post-Marketing Studies Experience 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 diseases Support cutting-edge therapies across inflammatory bowel disease, dermatology, rheumatology, respiratory, and other immune-mediated disorders Join a collaborative, sponsor-dedicated team focused on operational excellence Enjoy the flexibility of a fully remote US-based role Expand your impact across global clinical development programs and contribute to bringing life-changing therapies to patients Salary Range: $120,000-$135,000 This posting is intended for a [possible] upcoming opportunity rather than a live role. 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: 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. Get to know Syneos Health Additional Information Tasks, 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. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. 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 herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including 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. Summary Roles within Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study time-lines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures studies are conducted within clinical trial protocols, monitoring progress and following up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop trial recruitment strategies. Impact and ContributionIncludes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Supervises experienced support employees and/or entry individual contributors. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution. Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Syneos Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. #J-18808-Ljbffr Syneos Health, Inc.