Sr Clinical Project Manager - Early Phase

Syneos Health; California (MO); Hybrid; USD 110,000 - 165,000; Full time

Job summary

Syneos Health is seeking a Sr Clinical Project Manager for Early Phase to lead Phase I trials from startup through closeout. The role requires sponsor-facing leadership, cross-functional coordination, and adherence to GCP/ICH guidelines and TMF standards.

Ideal candidates bring strong budget management skills, experience with CTMS/eTMF systems, and the ability to navigate regulatory requirements while delivering on time and within budget. Willingness to travel as needed.

Qualifications

• Experience leading Phase I or early-phase trials.
• Proven ability to manage multiple projects in fast-paced CRO environment.
• Strong understanding of GCP, ICH, and regulatory requirements.

Responsibilities

• Lead all aspects of assigned early-phase trials from startup to closeout.
• Serve as primary liaison between sponsors, teams, vendors and sites.
• Develop and manage timelines, milestones, resources, risks, finances, and deliverables.
• Ensure projects align with protocols and budgets.
• Oversee TMF quality, inspection readiness, and study information in CTMS.
• Provide status updates to clients and senior leadership.

Skills

Phase I experience

Project leadership

GCP/ICH knowledge

Budget management

CTMS proficiency

Education

Bachelor's degree in Life Sciences or related

Tools

CTMS

eTMF

Job description

Sr Clinical Project Manager - Early PhaseSyneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.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 deliver – for one another, our customers, and, most importantly, for those in need.Discover what your 25,000 future colleagues already know: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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesPosition SummaryWe are seeking an experienced Clinical Project Manager, Early Phase Clinical Research to lead and oversee Phase I and early development clinical trials from study start-up through closeout. The successful candidate will serve as the primary point of contact for sponsors and internal stakeholders, ensuring studies are delivered on time, within budget, and in compliance with Good Clinical Practice (GCP), ICH guidelines, company SOPs, and regulatory requirements.This role requires strong project leadership, sponsor-facing experience, and a deep understanding of the unique operational challenges associated with early-phase clinical studies, including First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), proof-of-concept, Clinical Pharmacology and other exploratory clinical trials.Key ResponsibilitiesProject Leadership & Study DeliveryLead all aspects of assigned early-phase clinical trials from study startup through database lock and closeout.Serve as the primary liaison between sponsors, internal teams, vendors, and study sites.Develop and manage project timelines, milestones, resources, risks, finances, and deliverables.Ensure projects are executed according to contractual commitments, study protocols, and operational plans.Lead cross-functional project teams to achieve study goals while maintaining quality, timelines, and budget expectations.Coordinate activities and deliverables across internal departments and external partners.Financial & Operational OversightMaintain accountability for overall project financial performance, including budget management, forecasting, and change order identification.Monitor project scope and proactively manage risks, issues, and resource requirements.Develop contingency plans and risk mitigation strategies to ensure successful study execution.Provide regular project status updates and reports to clients and senior leadership.Quality & Regulatory ComplianceEnsure studies are conducted in compliance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements.Maintain oversight of Trial Master File (TMF) quality, completeness, and inspection readiness.Ensure accurate maintenance of study information within CTMS and other clinical systems.Support audit and inspection readiness activities throughout the study lifecycle.Maintain accountability for project documentation and all assigned study deliverables.Client & Stakeholder ManagementBuild strong relationships with sponsors through consistent communication and successful project delivery.Lead internal and external project meetings, including governance and study team meetings.Present project updates, risks, mitigation plans, and key milestones to clients and executive stakeholders.Participate in bid defense meetings and support business development initiatives as needed.Identify opportunities for future business and expanded client partnerships.Team LeadershipProvide leadership and direction to cross-functional study teams.Foster collaboration and accountability across operational functions.Mentor junior team members and clinical operations staff as appropriate.May provide line management responsibilities for project management and clinical monitoring personnel.Required QualificationsBachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific discipline; or an equivalent combination of education and experience.Minimum of 5+ years of clinical research experience with progressive project management responsibilities.Experience managing Phase I and/or early-phase clinical trials.Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.Demonstrated ability to manage multiple projects in a fast-paced clinical research environment.Strong financial management and budget oversight experience.Exceptional organizational, problem-solving, and risk management skills.Excellent verbal and written communication, presentation, and stakeholder management skills.Ability to work independently while effectively leading cross-functional teams.Proficiency with CTMS, eTMF, and related clinical trial technologies.Willingness to travel approximately 25%.Preferred QualificationsExperience within a Contract Research Organization (CRO).Direct experience supporting First-in-Human (FIH), SAD, MAD, clinical pharmacology (i.e. DDI, TQT, FE, BA/BE), or proof-of-concept studies.Experience managing studies involving healthy volunteers, specialty and/or patient populations.Vendor management and oversight experience.Previous people leadership or line management experience.Experience with decentralized and technology-enabled clinical trials.What Success Looks LikeDelivering studies on time, within budget, and with high quality.Building trusted partnerships with sponsors and investigative sites.Maintaining audit and inspection readiness.Proactively identifying and mitigating study risks.Successfully leading cross-functional teams through the complexities of early clinical development.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. Learn more about Syneos Health.http://www.syneoshealth.comAdditional 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. 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.