Clinical Trial Manager/Local Delivery Lead
Core
End-to-end leadership for US clinical study delivery, serving as the primary operational link between global study teams and local US operations to ensure recruitment, timelines, budget, and regulatory compliance.
Role type
Senior Clinical Trial Manager / Local Delivery Lead
Builds
Oncology medicine clinical trials (Phase I-III) including master protocols (umbrella, basket, platform)
Domain
Biopharmaceuticals / Oncology / Clinical Research
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Oncology trial management, Phase I-III study lifecycle management, master protocol design (umbrella/basket/platform), local US regulatory compliance (IND/GCP/ICH), matrix leadership, risk management, budget tracking, stakeholder management
Preferred skills
Master of Science or PhD, project management experience, deep knowledge of US human research regulations, problem-solving in matrix environments
Technologies
AI and digital tools for process streamlining
Responsibilities
Lead local study teams and cross-functional experts; serve as operational point-of-contact between central and US teams; manage recruitment targets and study timelines; identify and resolve risks impacting study delivery; ensure accuracy of study systems and trial master files; prepare local Informed Consent Forms and coordinate regulatory submissions; assist with audits and inspections.
Seniority
Senior, hands-on IC with strategic oversight
