Study Management Associate II - Virtual/Multiple Theraputic Areas
The Study Management Associate is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.
- Some positions may be office based in Lake County, IL
- 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 cross-functional 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 required, typically in nursing or scientific field; Associate's Degree, R.N. or equivalent with relevant experience is acceptable.
- May have at least 2 years Pharma-related/clinical research related experience or professional equivalent.
- Demonstrates analytical and critical thinking skills.
- Possesses good communication skills.