Global Sr Project Manager - FSP
Core
Lead global clinical study operations for a bio-pharma company, ensuring alignment between strategy and regional execution while managing cross-functional teams and vendors.
Role type
Senior Clinical Study Lead (Global)
Builds
Global clinical trials for bio-pharma assets
Domain
Bio-pharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
global clinical study management, cross-functional team leadership, vendor and CRO oversight, budget and resource management, risk and issue management, regulatory compliance (ICH-GCP), data oversight, strategic decision-making
Preferred skills
oncology experience, Phase II/III/IV trial experience, FDA/EMA/MHRA/PMDA inspection exposure, China/Japan/Africa market experience
Technologies
clinical study management systems
Responsibilities
Own day-to-day management of global clinical study; Lead cross-functional study teams; Develop and maintain study timelines, operational plans, and risk management plans; Manage external vendors and CRO partners; Monitor study budgets and forecasts; Identify study risks and lead mitigation; Ensure study conduct follows ICH-GCP and local regulations; Monitor enrollment and data quality; Make operational decisions impacting study delivery
Seniority
Senior, hands-on IC
