Associate, Study Management III

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $96.5k - $183.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Plan, execute, and manage one or more Phase 0–4 global clinical trials from inception through closure • Provide study-level oversight and leadership in a cross-functional global environment • Support strategic leadership through stakeholder engagement, strategy development, meeting facilitation, and documentation • Manage external vendors, including RFPs, selection, scopes of work, deliverables, and risks • Lead global recruitment strategy, feasibility, subject recruitment, retention, and mitigation planning • Lead cross-functional, vendor, and investigator meetings and provide regular study-status updates • Ensure inspection readiness and participate in related activities • Identify, mitigate, escalate, and manage study risks and issues • Co-develop and manage study materials, including protocols, regulatory submissions, informed consent, budgets, agreements, clinical study reports, training materials, newsletters, and presentations • Manage CTMS and eTMF for compliance, inspection readiness, trend analysis, and timelines • Support EDC, IRT, and ePRO design reviews, user acceptance testing, plans, risk indicators, access, queries, and system oversight • Manage investigational product and associated study supplies • Provide training to study team members and vendors • Support global submission strategies • Support process improvement initiatives or serve as a subject matter expert and/or mentor

🎯 Requirements

• Bachelor's Degree or OUS equivalent required • At least 4 years of progressive pharmaceutical-related or clinical research-related experience • High level of core and technical competencies • Competence in standard quality procedures, including SOPs, ICH/GCP, and global regulations • Experience using EDC, IRT, CTMS, and eTMF systems • Strong analytical and critical thinking skills • Excellent organizational and time management skills and strong attention to detail • Exceptional interpersonal and communication skills in a global setting • Proficient in business/technical English, oral and written • Proactive, collaborative mindset • Ability to work independently in a fast-paced global team environment • Preferred: exposure to study initiation through completion activities and global study exposure

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical insurance • Dental insurance • Vision insurance • 401(k) • Short-term incentive programs • Virtual/remote work option