Study Management Associate - Madrid, España - ABBVIE

ABBVIE

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).

Supports the Study Project Manager in leading the cross functional study team:o Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)o Responsible for regular updates to the crossfunctional team and stakeholders on study status; ensure our CTMS is up to date
Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie's processes and procedures and the applicable regulations.
Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
Proactively identify and resolve and/or escalate study related issues
Participates in process improvement initiatives
Bachelor's Degree or equivalent is required, typically in nursing or scientific field; Associate's Degree, R.N. or equivalent with relevant experience is acceptable.
Must have at least four years of Pharmarelated/clinical research related experience and demonstrated a high level of core and technical competencies.
Possesses good communication skills.
Preferred exposure to study initiation through study completion.