Clinical Trials Manager, Early Phase Oncology (Office Based)
Core
Drive end-to-end operational delivery of early-phase oncology trials, ensuring high-quality execution through cross-functional leadership and CRO/vendor oversight.
Role type
Senior Clinical Trials Manager (Early Phase Oncology)
Builds
In-house and/or hybrid model clinical trials for early-phase oncology pipeline
Domain
Biopharma / Oncology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, Clinical trial management, Regulatory expertise, CRO/vendor oversight, Risk identification, Timeline management, Budget development, RFP management, Scientific communication, SOP development
Preferred skills
Early Development experience, FDA/EMEA regulations knowledge, ICH Guidelines knowledge, GCPs knowledge
Technologies
None stated
Responsibilities
Coordinate and supervise all aspects of clinical study; Draft and coordinate review of study documents (protocols, consents, CRFs, monitoring plans, IBs, CSR); Maintain study timelines; Contribute to study budget and CRO selection; Manage CROs/vendors; Train CROs, vendors, investigators, and study coordinators; Participate in strategic initiatives and SOP implementation
Seniority
Mid-to-Senior, hands-on IC with supervision
