AbbVie Study Management Associate II - Virtual/Multiple Theraputic Areas in Lake County, Illinois

Study Management Associate II - Virtual/Multiple Theraputic Areas

USA, Illinois, Lake County

Research & Development

Requisition #1706794

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

Key Responsibilities Include:

  • 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.

Basic:

  • 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.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled