.Location: Barcelona, Spain (on-site) 3 days working from the office and 2 days working from home.The Global Study Associate Director (GSAD) is responsible for the delivery of clinical studies, including quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines.
The GSAD 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 GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study concept through to close-out and archiving.The GSAD 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 the study team and/or external partners.
The GSAD leads the study team and/or study oversight team in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, the appropriate study delivery model, 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.Typical Accountabilities: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 progresses 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 the study-specific communication plan.Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedforward for study team members to the appropriate AZ manager or CRO representative.Ensure sponsor oversight throughout the conduct of the study.
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.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.Responsible for CRO and other clinically outsourced third-party vendor oversight and ensure all external service providers 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 including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team