Project Manager II – Investigator Sponsored Research, Collaborative Studies
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: California • Colorado • United States
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Tech Stack
About the role
- 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
Requirements
- 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
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchclinical project managementstudy leadershipclinical trial lifecyclevendor oversightbudget managementGCPICH guidelinesregulatory requirementsCAPA
Soft skills
leadershipcommunicationproblem-solvingcollaborationrisk identificationissue resolutionorganizational skillstime managementaccountabilityinspection readiness
Certifications
PMPCCRACCRP