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Director Study Management Haematology

Detalles de la oferta

.Location: Barcelona, Spain (On-site) / 3 days working from the office and 2 days working from home.The Global Study Director (GSD) is a business-critical role within the Haematology organisation 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 GSD 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 GSD leads a cross-functional study team (core and extended) and provides the team with direction and guidance to enable successful study delivery. The GSD may provide input to early study planning activities based on operational expertise. The GSD is accountable to the CPT for the delivery of a study, or studies, according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The GSD will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery.The GSD leads the study team(s) and/or study oversight team(s) in accordance with the Study Delivery Optimization (SDO / Study Team Operating Model (STOM), AZ Project Management Framework and/or clinical outsourcing model/ Haematology Ways of Working, current clinical trial regulations (e.G., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.G. AZguidelines) and in line with AZ values and behaviors. The GSD is also responsible for providing expert input, guidance, direction, mentoring, and support to GSADs on all study related operational activities. The GSD will also provide advice and support to GSADs related to study team leadership, senior stakeholder management, conflict management, etc.GSDs will also lead other non-drug programs and improvement projects as required. The GSD may lead program level projects/initiatives, as needed.Typical AccountabilitiesLead and coordinate a cross-functional study team of experts in accordance with SDO/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.Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection.Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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