Global Study Associate Director Late Oncology

hace 1 mes

Barcelona, España Astrazeneca A tiempo completo

.Global Study Associate Director Late Oncology 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 study team and/or external partners. 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 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. 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, 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. 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 (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 ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team

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    hace 1 mes

    Barcelona, España Astrazeneca A tiempo completo

    Global Study Associate Director Late OncologyLocation: 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...

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    hace 1 mes

    Barcelona, España Astrazeneca A tiempo completo

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    hace 1 mes

    Barcelona, España Astrazeneca Gmbh A tiempo completo

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    Barcelona, España Astrazeneca Gmbh A tiempo completo

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    Barcelona, España AstraZeneca A tiempo completo

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    hace 1 mes

    Barcelona, España Astrazeneca Gmbh A tiempo completo

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    Barcelona, España Astrazeneca Gmbh A tiempo completo

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