Study Management Associate III

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.

Purpose:

The Study Management Associate III (SMA III) is responsible to connect science and operations to bring evidence generation to life through the execution of one or more Evidence Solutions GMA non-interventional research studies. The SMA III performs study related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.  The SMA III achieves these objectives via critical thinking, excellent communication, high accountability, a global mindset, and innovative solutions to address risks and challenges.

Responsibilities:

• Responsible for executing one or more elements of non-interventional research studies in compliance with applicable research standards and regulations and in accordance with Abbvie policies and procedures.
• Supports the Study Project Manager/Director:
  • Supports the preparation of Study Team meetings (Agenda/Minutes)
  • Responsible facilitating and communicating study-wide information to the cross-functional team and stakeholders on study status
  • Ensures CTMS and other critical systems are accurate and up to date
• Supports the development of the concept/protocol and associated systems and documents (ICF, eCRFs, PROs, 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 and delivering 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

Qualifications:

• Bachelor’s Degree or OUS equivalent degree required
• Must have at least four years of Pharma-related/clinical research related experience
• Demonstrated a high level of core and technical competencies through management of various components of research execution
• 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
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
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.

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