Clinical Project Manager II - Early Phase Oncology (Sponsor Dedicated/ Remote - US) Preference for Hybrid Foster City, CA-Based Candidates
About The Position
Syneos Health is a life sciences services organization that partners with companies across the drug development and commercialization continuum. The Clinical Solutions team acts with a drug development mindset, applying expertise to understand customer needs and shape solutions. This role is a sponsor-dedicated position supporting innovative Early Phase Oncology clinical trials in a fast-paced environment. The ideal candidate will take ownership of a study from start-up through closeout, driving execution day-to-day. This role requires strong operational leadership, accountability, and execution, with the ability to operate both strategically and tactically. The candidate will lead cross-functional teams and be involved in the details to keep studies moving forward. Experience with the unique operational complexities of dose escalation, dose expansion, safety review processes, protocol amendments, and early clinical development programs is essential. While remote candidates may be considered, priority will be given to candidates located in or near Foster City, California, with the ability to work onsite 2-3 days per week.
Requirements
- 3+ years of Clinical Project Management experience within clinical research.
- Experience independently managing clinical trials from study start-up through closeout.
- Direct Oncology clinical trial experience.
- Direct Early Phase Oncology clinical trial experience supporting Phase I, Phase Ib, and/or Phase II studies.
- Strong understanding of the unique operational requirements associated with Early Phase Oncology programs.
- Experience supporting dose escalation and/or dose expansion studies.
- Strong CRO/vendor management and oversight experience.
- Proven ability to independently drive study execution in fast-paced clinical environments.
- Experience managing cross-functional clinical trial activities within matrixed organizations.
- Comfortable balancing strategic oversight with hands-on operational execution.
- Thorough knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements.
- Strong understanding of operational considerations associated with Early Phase Oncology clinical trials.
- Strong working knowledge of Microsoft Word, Excel, and PowerPoint.
- Ability to interpret and explain protocol requirements, operational processes, and study expectations to teams and stakeholders.
Nice To Haves
- First-in-human (FIH) study experience.
- Experience supporting solid tumor and/or hematologic malignancy programs.
- Experience supporting global or multi-regional oncology studies.
- Experience working within sponsor-dedicated, biotechnology, or pharmaceutical environments.
- Experience supporting complex oncology protocols involving multiple cohorts or adaptive study designs.
Responsibilities
- Drive operational execution of Early Phase Oncology clinical trials from study start-up through database lock and closeout.
- Independently manage day-to-day study operations with minimal oversight.
- Own timelines, deliverables, risks, and issue resolution across multiple workstreams.
- Maintain deep operational awareness across all aspects of the trial.
- Ensure study milestones stay on track in a fast-paced environment with shifting priorities and competing demands.
- Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly.
- Support operational activities associated with dose escalation cohorts, dose expansion cohorts, safety review meetings, protocol amendments, enrollment management, and study execution activities.
- Monitor enrollment, site performance, data quality, and operational metrics to support successful study execution.
- Drive accountability across study teams to ensure timelines and deliverables are met.
- Lead vendor management activities and maintain strong oversight of external partners and CROs.
- Contribute to RFP development, vendor selection, and ongoing vendor performance management.
- Hold vendors accountable to timelines, deliverables, quality expectations, and issue resolution.
- Actively manage operational follow-through rather than relying solely on escalation pathways.
- Partner closely with CROs, monitoring teams, central laboratories, imaging vendors, and specialty oncology service providers.
- Lead cross-functional meetings with clear agendas, action-oriented discussions, and strong follow-up.
- Drive accountability across internal teams and external partners.
- Build strong collaborative relationships while effectively navigating challenging conversations and competing priorities.
- Mentor or support junior team members as needed.
- Operate confidently within a matrixed global environment with multiple stakeholders.
- Draft, review, and coordinate key study documents including protocols, informed consents, monitoring plans, investigator brochures, clinical study reports, and other essential study documentation.
- Support study budget tracking, forecasting, and operational planning activities.
- Review data listings and support interim and final reporting activities.
- Train CROs, investigators, study coordinators, and vendors on protocol and study requirements.
- Support inspection readiness activities and maintain compliance with GCP, ICH, and applicable regulatory requirements.
- Contribute to SOP development, process improvement initiatives, and operational best practices.
Benefits
- 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
- Flexible paid time off (PTO) and sick time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
