Early Clinical Scientist- Translational Medicine -FSP
Core
Coordinate the design, planning, and execution of early-phase clinical trials, ensuring compliance, data validity, and risk mitigation.
Role type
Senior Clinical Scientist (Early Phase)
Builds
Early-phase clinical trials for drug development programs
Domain
Biopharmaceuticals / Clinical Development
Deliverable
client delivery
Required skills
Early-phase clinical trial management, CRO oversight, clinical safety assessment, GCP/ICH regulatory compliance, protocol and clinical document authoring, cross-functional team leadership, project risk management, clinical data interpretation, site monitoring and training, scientific writing
Preferred skills
Experience with Clinical Trial Management Systems (CTMS) and Trial Master File (TMF), expertise in novel endpoints and biomarker collection, therapeutic area agility
Technologies
Clinical Trial Management Systems, Trial Master File systems, Microsoft Teams
Responsibilities
Coordinate design and execution of early-phase trials; oversee trials across programs ensuring compliance and data validity; manage internal and external team performance; conduct clinical safety assessments and risk management; provide real-time oversight to mitigate study risks; review and interpret clinical trial data; conduct on-site study monitoring and training; co-author protocols, investigator brochures, and clinical study reports; develop operational documents like monitoring plans and informed consent forms; manage trial activities and cross-functional coordination; perform project risk assessments and contingency planning.
Seniority
Senior, hands-on IC
