Study Management Associate

hace 1 semana


Madrid, Madrid, España ABBVIE A tiempo completo

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.


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