Global Clinical Trials Leadership
The Global Clinical Trials Leadership position oversees the execution of assigned large and/or complex clinical trials. Key responsibilities include study timelines, study budget, and ensuring study conduct is in accordance with Regulatory Requirements.
This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs). The balance of direct leadership versus oversight will vary accordingly.
Key responsibilities include:
* Leads cross-functional study teams responsible for clinical study delivery.
* Provides operational input into protocol development.
* Oversees set-up and maintenance of study systems.
* Ensures compliance with regulatory requirements.
* Identifies outsourcing needs and leads vendor engagement and management.
* Provides input into baseline budget and timeline development.
* Leads risk assessment and identifies mitigation strategies.
* Monitors progress and acts on any deviations from plan.