Syneos Health is a leading biopharmaceutical solutions organization dedicated to advancing cancer research and bringing innovative therapies to patients worldwide. They are seeking a Clinical Project Manager II with strong global oncology clinical trial experience to lead the operational execution of global oncology trials, ensuring compliance and efficiency throughout the study lifecycle.
Responsibilities:
- Support and partner with Clinical Study Leads and cross-functional study teams on global oncology trials
- Lead day-to-day study management activities across study startup, conduct, maintenance, and closeout
- Manage study timelines, deliverables, risks, and issue resolution
- Oversee external vendors, CROs, central laboratories, imaging vendors, and specialty providers
- Coordinate Clinical Trial Team (CTT) meetings and drive action item follow-up
- Support study-level planning, forecasting, and operational strategy execution
- Monitor study performance metrics and proactively identify areas requiring intervention
- Ensure inspection readiness and compliance with applicable regulations and sponsor requirements
- Collaborate with stakeholders across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and Quality
- Contribute to study status reporting and executive-level communications
- Support achievement of study milestones, enrollment targets, database locks, and study closeout activities
Requirements:
- Bachelor's degree in a scientific, healthcare, or related field
- 3+ years of Clinical Project Management experience supporting global oncology clinical trials
- Experience managing studies across multiple countries and regions (North America, Europe, Asia-Pacific, Latin America, or other global regions)
- Vendor management experience required
- Strong understanding of clinical trial operations and study lifecycle management
- Experience supporting Phase I, Phase II, Phase III, and/or Phase IV oncology studies
- Strong working knowledge of ICH-GCP guidelines and clinical research regulations
- Proficiency with Microsoft Office Suite
- Ability to work effectively within global, cross-functional matrix organizations
- Experience independently leading global oncology studies
- Experience supporting complex, multi-regional Phase II and Phase III programs
- Experience with early-phase oncology studies (Phase I/Ib)
- Experience with immuno-oncology, targeted therapies, cell therapy, or hematologic malignancies
- Familiarity with CTMS, eTMF, IRT/RTSM, and clinical data review platforms
- Experience working in sponsor-dedicated or FSP environments