Description
Project Manager II – Early Phase / Healthy Volunteer Studies (Sponsor Dedicated/Remote)
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:

PROJECT MANAGER II – SPONSOR DEDICATED (EARLY PHASE / HEALTHY VOLUNTEER STUDIES)

Location: Remote (U.S.-based candidates only)
We are seeking a highly capable and hands-on Project Manager II to support early-phase (Phase 1) clinical studies for a leading biopharmaceutical sponsor, in a fully sponsor-dedicated capacity. This is a high-ownership role designed for an experienced clinical professional who thrives in a fast-paced, lean environment. You will be fully embedded within the sponsor’s team and responsible for managing all aspects of study execution — with a focus on Phase 1 Healthy Volunteer trials in oncology and related therapeutic areas.
If you bring direct experience running early-phase studies and enjoy rolling up your sleeves to manage both strategy and day-to-day execution, this opportunity is for you.

PHASE 1 HEALTHY VOLUNTEER STUDY EXPERIENCE IS REQUIRED.

Be prepared to share specific examples of:

• Number of studies you’ve supported
• Your title and scope of responsibility (e.g., Project Manager)
• Study phase, design, and your contributions
• 5+ years of clinical research experience, with 2+ years in clinical project management or study leadership roles.
• Proven success operating in a lean, high-accountability environment with limited Clinical Operations support.
• Strong knowledge of clinical trial lifecycle, from startup to closeout, including vendor oversight and budget management.
• Expertise in GCP, ICH guidelines, and applicable regulatory requirements for early-phase trials.
• Experience working within a CRO setting in a sponsor-facing capacity is strongly preferred.
• Proficient in clinical systems (e.g., CTMS, eTMF, EDC) and project management tools.
• Bachelor’s degree in Life Sciences, Clinical Research, or a related field.

Advanced degrees or certifications (PMP, CCRA, CCRP) are a plus.

GET TO KNOW SYNEOS HEALTH

Over 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.com

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 at the M23 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. They ensure 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. Responsibilities include site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. These roles also involve monitoring progress and following up with team members and line managers when issues develop. Additionally, they implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies.Impact and ContributionRoles within Clinical Project Management job family at the M23 level significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By gathering input from cross-functional teams and creating detailed plans, these roles help ensure that deliverables are produced on schedule, contributing to the overall success of the clinical trials. Their oversight of operational aspects of clinical trials ensures consistency and adherence to SOP, GCP, and country regulations, which is crucial for the integrity and reliability of the study results. Additionally, their involvement in site and vendor selection, budget preparation, and monitoring progress helps maintain the smooth operation of clinical trials, ultimately contributing to the advancement of clinical research and development.Core Focus•Planning, directing, creating, and communicating clinical study timelines•Overseeing operational aspects of clinical trials•Ensuring consistency across clinical studies•Adhering to SOP, GCP, and country regulations•Selecting sites and vendors•Preparing clinical trial budgets•Monitoring progress and following up with team members and line managers•Implementing and preparing the clinical development strategy•Developing trial recruitment strategie

WHAT YOU WILL DO

• Serve as the day-to-day operational lead for assigned Phase 1 Healthy Volunteer trials, overseeing execution from startup through closeout.
• Lead cross-functional team meetings, vendor discussions, and site calls, ensuring timely issue resolution and seamless communication.
• Independently develop and manage study timelines, project trackers, and operational deliverables.
• Oversee site and vendor selection, budget planning, and resource tracking to ensure trials are executed within scope and on time.
• Ensure adherence to GCP, SOPs, and country-specific regulations, while maintaining consistency across studies.
• Monitor trial performance, drive risk identification and mitigation, and support resolution of operational and quality issues.
• Collaborate cross-functionally with teams including regulatory affairs, clinical development, data management, and safety.
• Contribute to inspection readiness, including TMF oversight, compliance tracking, and CAPA support.