Study Management Associate II/III - Multiple Therapeutic Areas

Employer
AbbVie
Location
Lake County, IL, US
Posted
Jun 21, 2019
Ref
1807662
Required Education
Bachelors Degree
Position Type
Full time

This role can be hired at a SMA II or a SMA III level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities

Location: This role is based out of AbbVie's HQ in North Chicago, IL. While some openings require full-time or part-time office-based employment, there are some openings where a full-time remote/home-based or AbbVie Affiliate-based employment arrangement is possible.

Matrix management of functional areas and/or study vendors to ensure clinical study(ies) execution occurs per timelines. Individual is aware of both internal and external business environments and their impact on studies and escalates performance issues to management with possible solutions

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

 


Study Management Associate II Requirements:

 

 

 

 

  • Bachelor's Degree or equivalent required, typically in nursing or scientific field; Associate's Degree, R.N. or equivalent with relevant clinical experience is acceptable.
  • May have at least 2 year Pharmaceutical / Biotech relate clinical research related experience or professional equivalent.
  • Demonstrates analytical and critical thinking skills
  • Must possesses good communication skills
  • Ability to adapt to a changing environment and handle multiple priorities

 


Study Management Associate III Requirements:

 

 

 

 

  • 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 4 years of Pharmaceutical / Biotech related clinical research related experience and demonstrated a high level of core and technical competencies.
  • Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance)Preferred exposure to study initiation through study completion
  • Demonstrates analytical and critical thinking skills
  • Must possess good communication skills
  • Ability to adapt to a changing environment and handle multiple priorities

 


At AbbVie we offer comprehensive benefits, 3 weeks paid vacation, 11 Company holidays, 3 personal days, a 401k, pension plan and a great place to work.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.