Study Management Associate III

Employer
AbbVie
Location
Lake County, IL
Posted
Oct 06, 2018
Ref
1801078
Discipline
Clinical, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time

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.

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

 


Qualifications :

Basic:

 

  • 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
  • Possesses good communication skills.
  • Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).

 


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Key Stakeholders :