Study Start Up Lead - Sponsor dedicated

Job description

The Study Start-Up (SSU) Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans. The Study Start-Up Lead works collaboratively with other key team members and leads the SSU Team as needed to accelerate study, country, and site activation. Key accountabilities: Early Planning and Team Leadership: - Contributes SSU insights to the development of the trial Operational Execution Plan - Configures and ensures proper trial-specific set-up of SSU systems - Prepares global SSU planning and leads SSU Team from kick-off through completion of SSU - Implements global aspects of protocol and OEP amendments, activates and oversees country implementation of amendments Global SSU Activation Leadership: - Ensures global trial templates are ready for country usage, global trial level document collected into eTMF, HA submissions done on time - Ensures timely global vendor activation - Directs the Study Grants Expert for investigator grant plan/fair market value assessment initiation and finalization of country site budget and con...