Senior Global Study Leader
Senior Global Study Leader, BioPharm
The Senior Global Study Leader (SGSL) is a business-critical role within Early BioPharm (CVRM or R&I) Study Management Operations whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, or across programs that are deemed most critical to the business. The SGSL is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery.
The SGSL may provide input to early study planning activities based on operational expertise. The SGSL is accountable to the CPT for the delivery of a study, or studies, according to agreed timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The SGSL will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery.
The SGSL is also responsible for providing expert input, guidance, direction, mentoring, and support to GSLs on all study related operational activities. The SGSL will also provide advice and support to GSLs related to study team leadership, senior stakeholder management, conflict management, etc. SGSLs will also lead knowledge management strategy and study related change management.
• Accountable from set-up through maintenance, close-out and study archiving for the operational planning, leadership and delivery of multiple studies or overseeing single, complex/novel studies (such as platform, basket, etc.) to time, cost, and quality.
• Contributes with expert clinical operational input into project strategy and study design/or documents ).
• May perform Study Management department leadership tasks as delegated by the Director, Study Management
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget. Ensure adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Accountable for leading the identification of overall study-level risk management activities. Ensure mitigation strategies are implemented effectively and that issue escalation pathways are clear to the entire study team.
• Oversee individual performance of study team members and ensure resource is utilized efficiently.
• University degree (or equivalent), preferably in medical or biological sciences or associated with clinical research
• Previous project management experience and able to lead multiple priorities
• Significant clinical trial experience in all phases of study delivery and relevant guidelines and regulatory requirements
• Proven experience in global study leadership and team leadership with practice of mentoring and empowering a team
• Strong strategic and critical thinking skills with strong resolution management skills
• Excellent communication and interpersonal skills
• Experience in external provider oversight and management
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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.