Global Study Associate Manager
The Senior Global Study Leader (Sr. GSL) is a business-critical role within AstraZeneca R&D China whose main accountability is the operational planning and delivery of high priority and/or complex clinical studies (often multiple) within or across programs. The Sr. GSL is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction, guidance and study management plans to enable successful study delivery. The Sr. GSL may provide input to strategy or early study planning activities based on operational expertise and may also be involved in submission planning activities if needed.
The Sr. GSL is accountable to the CPT for the delivery of a study according to agreed timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners. The Sr. GSL may interface with other internal stakeholders within Clinical Operations and Therapeutic Area (TA) function, and/or external partners, to identify, manage and resolve issues affecting study delivery.
The Sr. GSL leads the study team and/or study oversight team in accordance with AZ’s Study Team Operating Model (STOM), Project Management Framework and/or clinical outsourcing models (e.g. SCOUT), current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviors.
The Sr. GSL is also responsible for providing expert input, guidance, direction, mentoring, and support to GSLs on all study related operational activities. The Sr. GSL may provide advice and support to GSLs related to study team leadership, senior stakeholder management, conflict management, etc. The Sr. GSL may also lead other non-drug programs and improvement projects as required.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.