Clinical Trial Manager
Core
Lead the operational execution of clinical studies, ensuring compliance with protocols and regulations while managing site feasibility, recruitment, and data quality.
Role type
Senior Clinical Trial Manager (Oncology/Rare Disease)
Builds
Clinical studies for life sciences clients
Domain
Life Sciences / Clinical Research / Oncology
Required skills
Clinical trial planning and oversight, Site feasibility and recruitment strategy, Investigator relations, Regulatory compliance (ICH-GCP), Vendor management, Data quality monitoring, Budget and resource management, Training development
Preferred skills
Advanced degree in science or health-related field, Experience in Phase 1 FIH and healthy volunteer trials
Technologies
CTMS, Microsoft Office (Outlook, Word, Excel, PowerPoint), eTMF systems
Responsibilities
Serve as primary clinical point of contact with clients, Develop study documents and training materials, Generate site lists and drive feasibility processes, Oversee submissions to Competent Authorities and IRBs, Manage clinical monitoring strategies and CAPA plans, Support business development and marketing activities, Perform clinical data review and query generation
Seniority
Senior, hands-on IC with potential line management responsibilities
