![Astrazeneca Gmbh](https://media.trabajo.org/img/noimg.jpg)
Clinical Study Administrator
hace 21 horas
.Clinical Study Administrator The 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 objectives.Accountabilities Assists in coordination and administration of clinical studies from the start-up to execution and close-out.Collects, assists in preparation, reviews and tracks documents for the application process.Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.Serves as local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.Contributes to the production and maintenance of study documents, ensuring template and version compliance.Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.G. Enterprise Regulatory Vault) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.E. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.G. CTMS such as Veeva Clinical Vault, SharePoint, etc) and supports others in the usage of these systems.Prepares and/or supports contract preparation at a site level.Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.Manages and contributes to coordination and tracking of study materials and equipment.Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.Leads the practical arrangements and contributes to the preparation of internal and external meetings e.G. study team meetings, Monitors' meetings, Investigators' meetings.Liaises with internal and external participants and/or vendors, in line with international and local codes
-
Clinical Study Administrator
hace 1 día
Barcelona, España AstraZeneca GmbH A tiempo completoClinical Study Administrator The 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 objectives....
-
Clinical Study Administrator
hace 1 día
Barcelona, 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...
-
Aplica Ya Clinical Study Administrator
hace 21 horas
Barcelona, España Astrazeneca Gmbh A tiempo completo.Clinical 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...
-
Clinical Study Expert
hace 24 horas
Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completoJob DescriptionThe Clinical Study Expert is a key role within Bayer (Schweiz) Ag, responsible for ensuring the safety of study participants, the quality of data, and the success of development projects. As a member of the Global Clinical Sub-Team, this expert will provide expert knowledge and insight into clinical studies.
-
Clinical Study Manager
hace 6 meses
Barcelona, España Veranex, Inc. A tiempo completoVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Administrator, Clinical Trial Management Systems
hace 6 meses
Barcelona, España TFS HealthScience A tiempo completoOverview: TFS HealthScience is excited to be expanding our **Operational Strategy and Delivery Office (OSDO)** and we are looking for an experienced, highly motivated **Administrator, Clinical Trial Management Systems (CTMS) **who shares our vision of providing clinical research excellence. Our **Operational Strategy and Delivery Office (OSDO)** is a highly...
-
Clinical Study Excellence Scientist
hace 1 semana
Barcelona, España Bayer (Schweiz) Ag A tiempo completo.At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities...
-
Clinical Study Excellence Scientist
hace 2 semanas
Barcelona, España Bayer (Schweiz) Ag A tiempo completoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Clinical Study Excellence Scientist
hace 2 semanas
Barcelona, España Bayer (Schweiz) Ag A tiempo completo.At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities...
-
Clinical Study Excellence Scientist
hace 2 semanas
Barcelona, España Bayer (Schweiz) Ag A tiempo completoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Clinical Study Excellence Scientist
hace 1 semana
Barcelona, España Bayer (Schweiz) Ag A tiempo completoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility.We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Clinical Study Excellence Scientist
hace 3 meses
Barcelona, España Bayer A tiempo completoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Clinical Study Excellence Specialist
hace 2 días
Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completoAbout BayerBayer (Schweiz) Ag is a leading global healthcare company committed to developing innovative products that improve human health and quality of life.As a Clinical Study Excellence Scientist at Bayer, you will play a crucial role in ensuring the safety of study participants, the quality of data, and the success of our development projects.Job...
-
Study Support Administrator
hace 6 meses
Barcelona, España ICON plc A tiempo completoStudy Support Administrator - Office Based (Hybrid) At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as...
-
Clinical Study Excellence Scientist
hace 2 semanas
Barcelona, España Bayer (Schweiz) AG A tiempo completoAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Clinical Study Excellence Scientist
hace 1 semana
Barcelona, España Bayer (Schweiz) AG A tiempo completoAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Clinical Study Excellence Scientist
hace 1 semana
Barcelona, España Bayer (Schweiz) AG A tiempo completoAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Clinical Study Coordinator
hace 1 mes
Barcelona, España Mabxience A tiempo completoOverview: At MabXience, ensure the seamless execution and oversight of clinical trials under your responsibility, delegated to CROs.Guarantee that all trials are conducted within the established timelines and quality standards.Responsibilities: Manage the clinical trial plan , communicate any timeline deviations to the Medical Director, and participate in...
-
Clinical Study Delivery Lead
hace 3 semanas
Barcelona, Barcelona, España TFS HealthScience A tiempo completoAbout this RoleTFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.The Clinical Study Delivery Lead will be...
-
Clinical Study Delivery Director
hace 4 semanas
Barcelona, Barcelona, España Tfs Healthscience A tiempo completoTFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities and functional service (FSP) solutions.About the Role: The Evidence Delivery Director (EDD) will be responsible for the...