Associate, Study Management II

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $84.5k - $162k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Contribute to the planning, execution, and management of one or more Phase 0–4 global clinical trials • Support the Study Project Manager and cross-functional team with stakeholder engagement, meeting facilitation, documentation, deliverables, and timelines • Manage external vendors, including RFPs, vendor selection, scopes of work, deliverables, and risk management • Manage recruitment strategies and mitigation planning from country feasibility through subject recruitment and retention • 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 • Co-develop and manage protocols, regulatory submissions, study execution plans, informed consent, site budgets and 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 support, query resolution, and system oversight • Manage investigational product and associated study supplies • Provide training to study teams, vendors, and other stakeholders • Support process improvement initiatives or serve as a subject matter expert or mentor

🎯 Requirements

• Bachelor's Degree or OUS equivalent required • At least 2 years of pharma/device or clinical research related experience • Competency in standard quality procedures, SOPs, ICH/GCP, and Global Regulations • Analytical and critical thinking skills • Excellent organizational and time management skills • Strong attention to detail • Strong interpersonal and persuasive communication skills • Proficient in business/technical English, oral and written • Proactive, collaborative mindset • Ability to work independently in a fast-paced global team environment • Preferred: experience with one or more clinical trial systems, such as EDC, IRT, CTMS, or eTMF • Preferred: experience in one or more parts of a clinical trial

🏖️ Benefits

• Paid time off including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Remote/virtual work option • Equal opportunity employer; veterans and disabled applicants supported