Study Management Associate II – Clinical Trials
Company: AbbVie
Function: Research & Development – Clinical Operations
Employment Type: Full-Time
Job ID: R00138300
Location: Irvine, California, USA (Hybrid – U.S. AbbVie Offices)
Experience Required: Minimum 2 years of clinical research or pharma/device experience
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to discovering and delivering innovative medicines that address serious health conditions and unmet medical needs. With a strong focus across immunology, oncology, neuroscience, eye care, and aesthetics, AbbVie strives to make a lasting impact on patients’ lives worldwide through science, integrity, and innovation.
Position Overview
The Study Management Associate II (SMA II) is a key contributor within AbbVie’s centralized study management organization, supporting the planning, execution, and oversight of global Phase 0–IV clinical trials. Working closely with the Study Project Manager and cross-functional stakeholders, this role ensures studies are delivered with high quality, efficiency, and compliance while meeting timelines and budgetary expectations.
This position operates in a hybrid work model from any U.S.-based AbbVie office and plays an essential role in supporting AbbVie’s global clinical development strategy.
Key Responsibilities
Support end-to-end execution of one or more global clinical trials from study start-up through close-out
Partner with Study Project Managers and cross-functional teams to drive study deliverables, timelines, and documentation
Facilitate study-level and regional meetings, including agenda development, meeting minutes, and action tracking
Manage external vendors through RFP development, scope of work review, performance oversight, and risk mitigation
Support global patient recruitment and retention strategies, including feasibility assessment and mitigation planning
Lead assigned internal, vendor, and investigator meetings and provide regular study status updates
Ensure inspection readiness and support audit-related activities
Identify, escalate, and manage study risks and issues to support trend analysis and proactive mitigation
Develop, review, track, and maintain key study documents including study execution plans, informed consent forms, training materials, newsletters, and presentations
Manage and maintain clinical trial systems including CTMS, eTMF, EDC, IRT, and ePRO, ensuring compliance and data quality
Support investigational product and clinical supply management activities
Deliver training to study team members, vendors, and stakeholders as required
Contribute to process improvement initiatives and serve as a subject matter expert or mentor when needed
Required Qualifications
Bachelor’s degree or international equivalent in life sciences or a related field
Minimum 2 years of experience in pharmaceutical, medical device, or clinical research environments
Working knowledge of ICH-GCP, global regulations, SOPs, and quality standards
Ability to operate effectively in a cross-functional, global clinical trial environment
Preferred Qualifications
Experience with one or more clinical trial systems such as EDC, IRT, CTMS, or eTMF
Hands-on exposure to one or more phases of clinical trials
Prior experience supporting global or multi-country clinical studies
Required Skills & Competencies
Strong analytical and critical thinking skills with the ability to evaluate complex clinical and operational issues
Excellent organizational, time management, and prioritization skills
High attention to detail and commitment to quality
Strong written and verbal communication skills in professional English
Collaborative, proactive mindset with the ability to work independently in a fast-paced environment
Compensation & Benefits (U.S.)
Annual Base Salary Range: USD 82,500 – 157,500, based on experience, location, and internal equity
Comprehensive benefits package including medical, dental, vision insurance, paid time off, holidays, and retirement plans
Eligibility for short-term incentive and bonus programs
Equal Opportunity Statement
AbbVie is an equal opportunity employer committed to diversity, inclusion, and equal access to employment opportunities. Reasonable accommodations are available for qualified individuals throughout the recruitment process.
Recruitment Fraud Notice
AbbVie does not request payment, banking information, or sensitive personal data during any stage of recruitment. Candidates are advised to verify all communications claiming to represent AbbVie.
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