Country Study Start-Up Specialist I

Supports the Regulatory Affairs, Project Management- and Legal-Team in the Study Start-up-phase and in case of Amendment submissions for Clinical Trials and Real World Evidence (RWE) studies; Assists with local regulatory country requirements, reviewing/preparing local submission documents and performing submissions; Assists Project Management with the adaptation of the global Budget to country specific budget templates; Assists in negotiating site budgets and working closely with the clinical budget manager/team during negotiation and finalization of individual site budgets; Assists the legal team by distributing Clinical Trial Agreement templates to the sites and acting as a liaison in the contract administration process.