Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP).
In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM):
Responsible for oversight of the execution of studies in the assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
Oversight of strategic CRO partners and/or other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
Represent Clinical Operations to contribute to CDP by providing regional operational expertise and strategic, inputs including study feasibility, budget, and timeline for assigned clinical programs
Accountable for developing regional operational strategy for assi...