Xxd36 | Oncologylocal Study Associate Director
hace 4 días
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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Xxd36 | Oncologylocal Study Associate Director
hace 3 días
Barcelona, España Ares Consultores 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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XXD36 | Oncologylocal Study Associate Director
hace 4 días
Barcelona, España ARES CONSULTORES 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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XXD36 | Oncologylocal Study Associate Director
hace 6 días
Barcelona, España ARES CONSULTORES 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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Oncologylocal Study Associate Director
hace 3 meses
Barcelona, España Astrazeneca Gmbh A tiempo completo.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,...
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Oncologylocal Study Associate Director Solo Quedan 24H
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Barcelona, España Astrazeneca Gmbh A tiempo completo.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,...
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Global Study Associate
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[F-45] Global Study Associate
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[Oncology]Local Study Associate Director
hace 4 semanas
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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Global Study Associate Oncology
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Associate Director, Study Supply Management
hace 5 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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[Oncology]Local Study Associate Director
hace 4 semanas
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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Global Study Associate Director Haematology
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Global Study Associate Director Late Oncology
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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
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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...