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Study Management Associate II/III - Multiple Therapuetic Areas

Employer
AbbVie
Location
United States
Start date
Jun 8, 2021

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Job Details

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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 may be full-time or part-time AbbVie HQ (North Chicago) or AbbVie Affiliate office-based or full-time remote/home-based depending on business need.

 

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

Qualifications

 

Study Management Associate II Requirements:
  • Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable
  • Two years of Pharma-related/clinical research related experience or professional equivalent desired.
  • Demonstrates analytical and critical thinking skills.
  • Possesses good communication skills. 

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 four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
  • Possesses good communication skills.
  • 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.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
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.

Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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