Job Details

Overview

Project Manager II Early Phase / Healthy Volunteer Studies (Sponsor Dedicated/Remote) at Syneos Health. Fully sponsor-dedicated, remote (U.S.-based) role supporting early-phase (Phase 1) clinical studies for a leading biopharmaceutical sponsor. This is a high-ownership position embedded within the sponsor's team, focused on Phase 1 Healthy Volunteer trials in oncology and related therapeutic areas.

Responsibilities

• 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 regulatory affairs, clinical development, data management, and safety teams.
• Contribute to inspection readiness, including TMF oversight, compliance tracking, and CAPA support.

Qualifications

• Phase 1 Healthy Volunteer study experience is required.
• 5+ years of clinical research experience, with 2+ years in clinical project management or study leadership roles.
• Proven ability to operate in a lean, high-accountability environment with limited Clinical Operations support.
• Strong knowledge of the clinical trial lifecycle, vendor oversight, and budget management.
• Expertise in GCP, ICH guidelines, and applicable regulatory requirements for early-phase trials.
• Experience in a CRO setting in a sponsor-facing capacity is strongly preferred.
• Proficiency with clinical systems (e.g., CTMS, eTMF, EDC) and project management tools.
• Bachelor's degree in Life Sciences, Clinical Research, or related field; advanced degrees or certifications (PMP, CCRA, CCRP) are a plus.

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

Location

Remote (U.S.-based candidates only)

Why You Want to Work Here

• Autonomy to manage early-phase studies independently in a critical development space
• Sponsor-facing role with CRO-backed resources, tools, and career support
• Opportunity to contribute to first-in-human oncology research
• Remote flexibility to work from anywhere in the U.S. with global collaboration
• High-visibility position with clear opportunities for advancement into senior project leadership roles

Note

Phase 1 Healthy Volunteer experience is mandatory. To be considered, applicants should clearly outline: your direct involvement in Phase 1 HV trials, your role/title and scope of responsibility, and the number and types of studies supported.

Benefits & Additional Information

The company offers benefits such as health plans, 401k matching, potential to participate in an Employee Stock Purchase Plan, and paid time off. Salary range will be based on qualifications and experience.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success, translating clinical, medical affairs, and commercial insights into outcomes. We collaborate across functional service provider partnerships or full-service environments to deliver therapies faster while changing lives.