Project Manager II - Early Phase / Healthy Volunteer Studies (Sponsor Dedicated/Remote)

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:

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

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.

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.

Skills and Experience You Have

• 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.

Why You Want to Work Here

• Lead with autonomy: Manage early-phase studies independently, driving execution in a critical development space.

• Be sponsor-facing, stay CRO-supported: Enjoy full sponsor integration while maintaining CRO resources, tools, and career support.

• Advance first-in-human research: Play a direct role in launching promising oncology treatments into clinical evaluation.

• Remote flexibility: Work from anywhere in the U.S. while collaborating with global teams.

• Grow intentionally: This is a high-visibility position with clear opportunities for advancement into senior project leadership roles.

Why Join Us?

In this role, you'll go beyond timelines and trackers - you'll help launch the very first trials of tomorrow's most innovative therapies. As part of a sponsor-dedicated team within a global CRO, you'll benefit from the agility of sponsor-side collaboration and the support of a full-service organization behind you.

If you have the early-phase experience and drive to lead with confidence and precision, we'd love to hear from you.

Note:

Phase 1 Healthy Volunteer experience is mandatory. To be considered, your application must clearly outline:

• Your direct involvement in Phase 1 Healthy Volunteer trials

• Your role/title and scope of responsibility

• Number and types of studies supported

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

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.

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 Contribution Roles 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 strategies