Study Management Associate (SMA) II

AbbVie • North Chicago, IL

274d • $106,296 - $153,000 • Remote

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Requirements

• Must have a Bachelor's or foreign education equivalent.
• 2 years of clinical research work experience.
• 2 years in applying standard quality procedures to full clinical trials, including SOP, ICH/GCP, Global Regulations.
• 2 years working with ICFs, protocols, & amendments.
• 2 years functioning independently in a matrixed environment with teams in multiple time zones.
• 2 years using 1 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging.
• 2 years analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study.
• 2 years managing meetings (creating agendas, preparing minutes, or presenting).
• 2 years ensuring data is clean, documents are accurate to maintain inspection readiness.

Responsibilities

• Contribute to global clinical trials from inception to closure, with support from the Study Project Manager (SPM) & in compliance with quality standards.
• Drive deliverables & timelines; lead & manage meetings with stakeholders.
• Manage vendors, recruitment, CTMS & eTMF.
• Maintain Inspection Readiness; identify, mitigate & manage risks.
• Develop & manage study materials; provide training to stakeholders.
• Support EDC, IRT, & ePRO design specifications, user acceptance testing, plans & key risk indicators, & system management activities.
• Manage IP & study supplies.
• Support process improvement initiatives & serve as a subject matter expert &/or mentor.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Short-term and long-term incentive programs

What This Job Offers

• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree