.Job Summary: The jobholder, an SME for local/regional regulations, works with multiple vendors, drives and coordinates activities across a range of stakeholders in support of site start up delivery. This role liaises with Covance Regulatory to ensure compliance, coordinates best practice solutions within region and coaches others in the more complex areas of SU. The Senior SU Specialist proactively anticipates and mitigates issues that could delay start up across a range of sites. Is the escalation point for negotiations with SUPM/SUCM's on behalf of less senior colleagues.Essential Job Duties: These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and dutiesThese are the specific areas of accountability requiring decisions or delivery of results. Most positions have between six to ten key job duties. In this section, list and describe the position's principal responsibilities in concise, but comprehensive statements. Include those accountabilities that are critical to the successful performance of the job. Indicate % of time in a single work week spent on top 5-10 duties (no less than 5% increments). Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements. When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness. Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required. Ensure efficient in country execution and local improvements aligned with global requirements. Review and approve projections and timelines to study teams, ensuring that they accurately represent the country's performance and suggests mitigation actions in agreement with SUCM. Develop project specific plans for the Site Activation component of assigned studies When appropriate, take a lead in team meetings to resolve issues and progress the trial Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM