Miriam Saz Delgado
Lecturer at IRYCIS- Claim this Profile
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Bio
Experience
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IRYCIS
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Spain
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Wellness and Fitness Services
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1 - 100 Employee
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Lecturer
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Jan 2022 - Present
Course of Good Clinical Practice for investigators and collaborators of Clinical trials ICH E6 (R2) Course of Good Clinical Practice for investigators and collaborators of Clinical trials ICH E6 (R2)
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Spanish Clinical Research Network (SCReN)
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Spain
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Hospitals and Health Care
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1 - 100 Employee
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Clinical Project Coordinator and Senior CRA
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Apr 2021 - Present
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Clintec
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United Kingdom
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Pharmaceutical Manufacturing
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100 - 200 Employee
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CRA II
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Sep 2017 - Apr 2021
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TFS HealthScience
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Sweden
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Pharmaceutical Manufacturing
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300 - 400 Employee
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CRA
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Feb 2016 - Sep 2017
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Dynamic Solutions
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Nov 2014 - Feb 2016
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Apr 2014 - Nov 2014
Start-up activities such as Site Regulatory Package collection, Clinical Site Agreement negotiation, and all supporting site management activities to ensure timely site initiation.Safety management (SAEs, SUSAR).Preparation, performance and follow-up of initiation, monitoring and close-out visits.Trial Master File updating and maintenance.Study Medication Management.Administrative processing of Clinical Trial documentation.I am working in different therapeutics areas as HEMATOLOGY, ONCOLOGY, ALLERGOLOGY and AIDS/VIH. Show less
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Astellas Pharma US
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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CRA junior
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Oct 2014 - Oct 2014
Monitoring visits, activities: preparation of the necessary documentation as applicable from the previous visit to resolve open action items; informed consent forms review, and accurate completion of the eCRF. Reviewing study case report forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries. Therapeutic area: ONCOLOGY ( Observational study: prostate cancer) Monitoring visits, activities: preparation of the necessary documentation as applicable from the previous visit to resolve open action items; informed consent forms review, and accurate completion of the eCRF. Reviewing study case report forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries. Therapeutic area: ONCOLOGY ( Observational study: prostate cancer)
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Farmaceutica
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Dec 2013 - Jun 2014
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Farmacia Villagrá Blanco C.B
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Madrid
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Farmacéutica Adjunta
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May 2011 - Sep 2013
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Education
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Universidad Autónoma de Madrid
Curso de Gestión de Proyectos en Investigación Clínica", Gestión de la investigación y del desarrollo -
Universidad de Valladolid
Curso de Farmacovigilancia para profesionales sanitarios -
Fundación Esame Madrid- Universidad Autónoma de Madrid
Máster en Monitorización de Ensayos Clínicos -
Universidad Complutense de Madrid
Licenciada en Farmacia