Syneos Health is looking for a Project Manager II to serve as the operational lead for assigned Phase 1 Healthy Volunteer trials. This sponsor-dedicated role offers high ownership, overseeing execution from startup through closeout in a fast-paced, lean environment.
What You'll Do
- Lead cross-functional team meetings, vendor discussions, and site calls to ensure timely issue resolution.
- Independently develop and manage study timelines, project trackers, and operational deliverables.
- Oversee site and vendor selection, budget planning, and resource tracking.
- Ensure adherence to GCP, SOPs, and country-specific regulations across studies.
- Monitor trial performance, drive risk identification and mitigation, and support issue resolution.
- Collaborate cross-functionally with teams including regulatory affairs, clinical development, data management, and safety.
- Contribute to inspection readiness through TMF oversight, compliance tracking, and CAPA support.
What We're Looking For
- Phase 1 Healthy Volunteer study experience is required.
- 5+ years of clinical research experience.
- 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 the 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.
- Proficient in clinical systems and project management tools.
- Bachelor’s degree in Life Sciences, Clinical Research, or a related field.
Nice to Have
- Experience working within a CRO setting in a sponsor-facing capacity is strongly preferred.
- Advanced degrees or certifications (PMP, CCRA, CCRP) are a plus.
Technical Stack
- CTMS
- eTMF
- EDC
- Project management tools
Team & Environment
Fully embedded within the sponsor’s team in a sponsor-dedicated capacity.
Benefits & Compensation
- 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
- Flexible paid time off (PTO) and sick time
Work Mode
This is a remote position open to candidates in the U.S.
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.
