Global Study Leader
Provides support and advice on the process of clinical trials and studies as an expert or through the supervision of a local or global team. Recognised expert within own field and often first point of contact for related queries. Will provide process support as an expert or project manager supervising a range of projects.
The Global Study Leader (GSL) is a business-critical role within AstraZeneca Global Medicines Development (GMD) whose main accountability is the delivery of clinical studies. The GSL 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 GSL is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSL is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.
The GSL leads the study team and/or study oversight team in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework and/or clinical outsourcing model (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.
• Lead and coordinate a cross-functional study team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
• Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
• For outsourced studies, be the primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations)
• Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs
• Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented
• Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
• Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations
• Identify and report quality issues that have occurred within the study in accordance with relevant AZ SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency)
• The GSL is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
• Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSL is the primary Study Management & Operations (SMO) point-of-contact in the event of an audit or inspection
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
• Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• 7 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience
• Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
• Demonstrated solid project management skills and knowledge of relevant tools
• Strong, demonstrated abilities/skills in team leadership
• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills
• Excellent communication and interpersonal skills
• Strong strategic and critical thinking abilities
• Strong organizational and problem-solving skills
• Ability to manage competing priorities
• Advanced degree, Masters level education (or higher)
• Project management certification
• Proven project management experience on a global level
• Experience in all phases of a clinical study lifecycle
• Proficiency in Microsoft Project
【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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.