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.
Role type
Senior Clinical Trial Manager / Local Delivery Lead
Builds
US clinical studies for vaccines and medicines
Domain
Pharmaceutical industry, Oncology Medicine, Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Oncology Medicine trial management, Phase I-III trial experience, Master protocols (umbrella/basket/platform), GCP/ICH guidelines, local US regulatory compliance, matrix leadership, risk management, budget tracking, site/vendor management
Preferred skills
Unblinded trial management, advanced project management, deep knowledge of US human research regulations, protocol adaptation to local environment
Technologies
Clinical Trial Management Systems (CTMS), AI and digital tools
Responsibilities
Lead local study teams and cross-functional experts to achieve recruitment, timeline, budget, and quality targets; serve as operational point-of-contact between central and US teams; proactively identify and resolve risks impacting study delivery; ensure accuracy of study systems and reporting; prepare local Informed Consent Forms and coordinate submissions to Regulatory Authorities and Ethics Committees; manage local budgets and assist with audits/inspections.
Seniority
Senior, hands-on IC with strategic oversight