Global Study Manager
hace 6 días
Are you ready to make a difference in the world of clinical research? As a Global Study Manager (GSM) within Development Operations, you will be an integral part of the global study team, supporting the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study Report (CSR) to study archiving. You will collaborate with internal and external partners to ensure the successful execution of delegated aspects of clinical studies across various therapeutic areas and phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).Your role will involve driving scope of work discussions, overseeing day-to-day activities delegated to vendors, providing status updates, and developing, reviewing, and approving related study documents.AccountabilitiesThe strategy, set up and oversight of key vendors in support of study deliverables according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the vendors is maintained and documented through the life cycle of the study.Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure efficient study delivery to time, costs and quality objectives.Contributes to the planning and conduct of internal and external meetings (e.g., Investigators'/Monitors' meeting).Supports the Study Lead with budget management, such as external service provider invoice reconciliation.Supports the Study Lead (GSAD, GSD) with developing and maintaining relevant study documents/plans (e.g., global study management plan and its relevant components).Perform Study Lead activities for less-complex studies (e.g., small studies, studies in conduct or close-out, OLE, etc.).Delegate and oversee team member responsibilities.Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices.Participate in and/or lead departmental initiatives and/or SME function.Coordination and reporting of start-up and recruitment activities at the study level, across all countries.Monitoring and site oversight globally on assigned study(ies), representing the monitoring function on the CTT.Aggregation and communication of deliverables for assigned study(ies), globally, to the CTT and country teams respectively.Resourcing (with assistance of country teams) and study-related training of CRAs for assigned study(ies).Developing and/or reviewing applicable study documents including, but not limited to, training materials, clinical monitoring and oversight plans.Coordinating country teams activities related to key study events, such as protocol amendments, interim database locks, and Investigator Meetings.
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Global Study Manager
hace 1 mes
España AstraZeneca GmbH A tiempo completoAre you ready to make a difference in the world of clinical research? As a Global Study Manager (GSM) within Development Operations, you will be an integral part of the global study team, supporting the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study...
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Global Study Associate
hace 3 semanas
España AstraZeneca A tiempo completoLocation: Barcelona (On-site). We require 3 days working from the office and 2 days working from home.Type of Contract: 1 year Fixed term contract.The Global Study Associate (GSA) is a vital member of the extended global study team, supporting the delivery of clinical studies within Late Development Oncology (LDO) to time, cost, and quality standards. From...
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[Oncology]Local Study Associate Director
hace 4 semanas
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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Study Operations Manager I
hace 3 semanas
España Parexel International A tiempo completoAt Parexel FSP, people make a difference. We have a key mission: to prevent and treat disease by bringing important new medicines and therapies to patients in need. We achieve this important goal through the expertise, experience, innovation, and commitment of our employees around the world.Our employees have the opportunity to do meaningful things around...
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Study Start Up Manager-spain-homebased
hace 2 semanas
España NonStop Consulting A tiempo completoPara aquellos profesionales de investigacion clinica que quieren dejar de viajar o profesionales con experiência previa en study start up que quieren convertirse en Manager, se trata de una vacante indefinida como Study Start Up Manager. La empresa es una CRO de tamaño medio. La vacante puede ser office based en Madrid o homebased en cualquier parte de...
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Senior Clinical Study Administrator |
hace 6 días
España ARES CONSULTORES A tiempo completoLocation: Barcelona, SpainJob reference: R-212623Date posted: 11/07/2024This is what you will do:The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start-up to execution and close-out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost, and quality...
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Freelance Clinical Study Coordinator
hace 2 días
España EPM Scientific A tiempo completoEPM Scientific are partnering with a European Biotechnology client who are seeking some freelance support for a Clinical Study Coordinator to assist at site level in Spain. They would ideally like this person to start as soon as possible but can have some level of flexibility. The client is also considering Freelance CRAs with a Study Coordinator background...
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Freelance Clinical Study Coordinator
hace 1 día
España Epm Scientific A tiempo completoEPM Scientific are partnering with a European Biotechnology client who are seeking some freelance support for a Clinical Study Coordinator to assist at site level in Spain. They would ideally like this person to start as soon as possible but can have some level of flexibility. The client is also considering Freelance CRAs with a Study Coordinator background...
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Freelance Clinical Study Coordinator
hace 2 días
España EPM Scientific A tiempo completoEPM Scientific are partnering with a European Biotechnology client who are seeking some freelance support for a Clinical Study Coordinator to assist at site level in Spain. They would ideally like this person to start as soon as possible but can have some level of flexibility. The client is also considering Freelance CRAs with a Study Coordinator background...
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España LHH (Global) A tiempo completoGlobal Candidate Services Manager - Global Delivery ServiceThe Global Candidate Services Manager is responsible for leading our centralized delivery operations teams. Partnering with in country and global delivery operations leaders to standardize, simplify and centralize back office and candidate support tasks whilst maintaining quality delivery, exceeding...
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Clinical Study Administrator
hace 4 semanas
España AstraZeneca GmbH A tiempo completoClinical Study AdministratorThe Clinical Study Administrator (CSA) plays a crucial role in the coordination and administration of study activities from start-up to execution and close-out. Working within the Local Study Team (LST), the CSA ensures the quality and consistency of interventional study deliverables, meeting time, cost, and quality...
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Associate Project Manager | NO246
hace 6 días
España ARES CONSULTORES A tiempo completoWe currently have an exciting new opportunity for an Associate Project Manager to join our growing team, sponsor dedicated.The Associate PM is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management. This is a permanent role with ICON and fully home-based.You must be...
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Freelance Clinical Study Coordinator
hace 3 horas
españa EPM Scientific A tiempo completoEPM Scientific are partnering with a European Biotechnology client who are seeking some freelance support for a Clinical Study Coordinator to assist at site level in Spain.They would ideally like this person to start as soon as possible but can have some level of flexibility.The client is also considering Freelance CRAs with a Study Coordinator background...
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Director, Global Regulatory Affairs Study Start Up
hace 2 semanas
España CTI Clinical Trial and Consulting Services A tiempo completoDirector, Global Regulatory Affairs Study Start Up (level dependent on experience) - This position is open to candidates globallyManages and oversees global RASSU activities.Provides guidance to RASSU regional leaders and fosters their collaboration and growth.Ensures clinical study timelines, budgets, and quality measures are met and meet / exceed accepted...
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Global Trials Associate J-155
hace 6 días
España ARES CONSULTORES A tiempo completoPosition Summary: The GCO Leadership Development Program consists of 12 months of dynamic rotations with in-depth training across the CTA, SM, and LTM roles, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development, and dynamic real-world work experience. Global Trial Associates (GTAs) will rapidly gain...
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Sponsor Dedicated Global Project Manager II
hace 5 días
España Syneos Health, Inc. A tiempo completoSponsor Dedicated Global Project Manager II - Home Based in SpainUpdated: November 22, 2024Location: Spain-Europe - ESP-Home-Based (Barcelona)Job ID:24006371Sponsor Dedicated Global Project Manager II - Home Based in SpainGlobal Study management and project management experience is required.Experience in Phase I and/or Phase IV studies is preferred.Syneos...
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Study Nurse/Clinical Research Nurse
hace 6 días
España IQVIA Argentina A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company? If so, come and join us - IQVIA is looking for a Clinical Research Nurse.This part-time (24 hours) role is planned for 12 months and is to support the site in Segovia in conducting a clinical trial.As a pivotal member of the site team, you will be...
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GLOBAL TRIALS ASSOCIATE
hace 6 días
España ARES CONSULTORES A tiempo completoPosition Summary:The GCO Leadership Development Program consists of 12 months of dynamic rotations with in-depth training across the CTA, SM, and LTM roles, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development, and dynamic real-world work experience.Global Trial Associates (GTAs) will rapidly gain...
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Study Nurse/Clinical Research Nurse
hace 6 días
España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry-leading company? If so, come and join us - IQVIA is looking for a Clinical Research Nurse. This part-time (24 hours) role is planned for 12 months and is to support the site in Segovia in conducting a clinical trial. As a pivotal member of the site team, you will be...
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Study Start Up Associate I
hace 4 semanas
España ICON Strategic Solutions A tiempo completoAs a Study Start Up Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The SSUA is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in...