Study Management Associate
hace 1 semana
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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