Oncologylocal Study Associate Director
hace 1 mes
.AstraZeneca is expanding our therapeutic area into cell therapy, and therefore searching for potential leaders who can manage cell therapy clinical studies.LSAD is to lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.The Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.[Typical Accountability]Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans
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Associate Director, Study Management
hace 6 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona**: Join our Biopharmaceuticals R&D team as an Associate Director, Study Management. In this role, you will provide oversight for Study Supply Management activities, ensuring delivery across a breadth of supply functions within the LCS (Logistics and Clinical Supply) matrix. You will independently plan, handle and deliver all aspects of...
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Global Study Associate Director Late Oncology
hace 7 días
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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Global Study Associate Director Late Oncology
hace 7 días
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...
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Global Study Associate Oncology
hace 7 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona - On-Site** The GSA is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP)development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSA...
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[Oncology]Local Study Associate Director
hace 1 mes
Barcelona, España AstraZeneca GmbH A tiempo completoAstraZeneca is expanding our therapeutic area into cell therapy, and therefore searching for potential leaders who can manage cell therapy clinical studies.LSAD is to lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents,...
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[Oncology]Local Study Associate Director
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completoAstraZeneca is expanding our therapeutic area into cell therapy, and therefore searching for potential leaders who can manage cell therapy clinical studies.LSAD is to lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents,...
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Associate Director, Study Supply Management
hace 3 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (On-site): We requiere 3 days working from the office and 2 days working from home.**: Join our Biopharmaceuticals R&D team as an Associate Director, Study Management. In this role, you will provide oversight for Study Supply Management activities, ensuring delivery across a breadth of supply functions within the LCS (Logistics...
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Global Study Associate Director
hace 2 meses
Barcelona, España AstraZeneca A tiempo completoWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the...
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Barcelona, España Astrazeneca Gmbh A tiempo completo.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...
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Global Study Associate Director Late Oncology
hace 7 días
Barcelona, España Astrazeneca Gmbh A tiempo completo.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...
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Global Study Associate Director Late Oncology
hace 7 días
Barcelona, España Astrazeneca Gmbh A tiempo completo.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...
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Associate Director Study Data Manager
hace 2 meses
Barcelona, España AstraZeneca A tiempo completoAre you ready to take the lead in coordinating Clinical Data Management (CDM) deliverables on assigned clinical studies? As an Associate Director Study Data Manager, you will be a key member of the Global Study Team (GST) and the primary point of contact for the Data Management (DM) vendor. Your role will be pivotal in ensuring CDM deliverables follow...
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Global Study Associate Director
hace 5 meses
Barcelona, España AstraZeneca A tiempo completoLocation: Barcelona Are you ready to follow the science and make a difference? As a Global Study Associate Director (GSAD) at AstraZeneca, you will be at the forefront of our mission to push the boundaries of science and deliver life-changing medicines. This role is a key player within our Study Management, BioPharmaceuticals Clinical Operations team,...
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Global Study Associate Director Haematology
hace 6 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (on-site)** The **Global Study Associate Director (GSAD)** is a business-critical role within Study Management R&D, Development Operations, whose main accountability is the delivery of clinical studies. The **GSAD** is responsible for leading a cross-functional study team (core and extended) and for providing the team with...
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Global Study Associate Director Late Oncology
hace 1 semana
Barcelona, España Astrazeneca A tiempo completoGlobal 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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Global Study Associate Director Late Oncology
hace 7 días
Barcelona, España Astrazeneca A tiempo completoGlobal 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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Global Study Associate Director Haematology
hace 3 meses
Barcelona, España AstraZeneca A tiempo completo**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...
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Global Study Associate Director Late Oncology
hace 7 días
Barcelona, España Astrazeneca A tiempo completoGlobal 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...
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Global Study Associate
hace 5 meses
Barcelona, España AstraZeneca A tiempo completoAre you ready to join our Early Oncology Study Management Team at AstraZeneca and make a difference for patients living with cancer? At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to...
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Global Study Associate Director Late Oncology
hace 1 semana
Barcelona, España AstraZeneca A tiempo completoGlobal 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...
