Senior Clinical Project Manager / Senior Clinical Study Manager

Oncology Clinical Development | Early Phase Biotech A rapidly growing clinical‑stage biotechnology organization is seeking two experienced Senior Clinical Project Managers / Senior Clinical Study Managers to support the execution of global oncology clinical trials across early and late‑stage development. These individuals will play a critical role in leading complex international studies, including First‑in‑Human (FIH) programs involving novel biologic therapies. This is an opportunity to join a highly collaborative and scientifically driven clinical operations team focused on advancing innovative oncology treatments in a fast‑paced development environment. Key Responsibilities Lead the end‑to‑end operational execution of global Phase I–III oncology studies from startup through closeout Oversee timelines, budgets, quality, and cross‑functional deliverables to ensure successful study execution Support protocol development, country/site activation strategies, enrollment planning, and study reporting activities Drive operational excellence across complex oncology programs, including FIH and registration‑enabling studies Study Oversight & Vendor Management Manage CROs and external vendors across monitoring, data management, imaging, laboratories, ePRO, and related services Proactively identify operational risks and implement mitigation strategies Ensure inspection readiness and compliance with ICH‑GCP, SOPs, and global regulatory requirements Oversee forecasting, accruals, budget tracking, and change order management Cross‑Functional Collaboration Lead global study team meetings and facilitate effective decision‑making across stakeholders Partner closely with Clinical Development, Medical, Regulatory, Biometrics, Safety, and external collaborators Build and maintain strong relationships with investigators, academic institutions, and key external partners Qualifications 10+ years of clinical operations experience within biotech, pharma, or CRO environments 5+ years leading global oncology clinical trials Strong experience supporting early phase oncology studies, including FIH, dose escalation, and expansion cohorts Demonstrated success managing global CROs and multi‑vendor clinical programs Deep understanding of oncology drug development and complex clinical trial operations Strong knowledge of ICH‑GCP and global regulatory standards Excellent leadership, communication, and stakeholder management skills Ability to operate independently in a fast‑paced and evolving environment Preferred Qualifications Background Experience with immuno‑oncology, targeted therapies, or solid tumor indications Exposure to registration‑directed or late‑stage studies Prior experience within small or emerging biotech companies Advanced scientific degree and/or project management certification preferred Why This Opportunity? High visibility role within a growing oncology organization Opportunity to lead innovative global oncology studies from early development onward Collaborative, science‑driven culture with strong executive exposure Meaningful impact on cutting‑edge therapies for patients with unmet medical needs #J-18808-Ljbffr RBW Consulting LLP