Associate, Study Management II (Remote)

Role Summary

Associate, Study Management II (Remote) will be part of a dynamic, centralized study management team responsible for the execution of global clinical trials and will be a key member of the study team. The role supports planning, executing, and managing one or more Phase 0-4 clinical trials under guidance, ensuring quality, timeliness, and budget adherence in alignment with AbbVie standards. This is a global, potentially virtual position.

Responsibilities

• The Study Management Associate II contributes to one or more global trials in a cross-functional environment from inception through closure, in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies).
• Support the Study Project Manager and cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including meeting facilitation and timely documentation at study and regional levels.
• Vendor management including RFP/initiation, selection, scope of work development and review, deliverable oversight, and risk management for external vendors (e.g., central lab, recruitment, imaging, committees).
• Recruitment management with global strategy development and mitigation planning from feasibility through subject recruitment and retention.
• Lead assigned meetings (cross-functional, vendor, and/or investigator) and provide regular updates on study status (agenda development, minutes, filing).
• Ensure inspection readiness and participate in related activities.
• Identify, mitigate, and manage risks, including timely issue review, escalation, and trend analysis to support risk prevention.
• Co-develop and manage study materials (protocols, regulatory submissions, study execution plan, informed consent, budgets, agreements, clinical study report, training materials, newsletters, presentations) and manage CTMS/eTMF to ensure compliance/inspection readiness and timelines.
• Manage EDC, IRT, and ePRO: review design specs, participate in UAT, contribute to plans and KPIs, and perform system management activities like access support and query resolution.
• Manage investigational product and other study supplies.
• Provide engaging training to identified stakeholders as needed (study team members, vendors).
• Support process improvement initiatives or serve as a subject matter expert and/or mentor.

Qualifications

• Bachelor’s Degree or OUS equivalent required
• At least 2 years of pharma/device or clinical research experience with core and technical competencies
• Competent in standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Analytical and critical thinking skills to evaluate complex issues and contribute to strategy and decision making
• Excellent organizational and time management skills, strong attention to detail; strong interpersonal 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 1+ clinical trial systems (e.g., EDC, IRT, CTMS, eTMF) and experience in 1+ parts of a clinical trial

Skills

• Clinical study oversight
• Vendor and recruitment management
• Meeting leadership and stakeholder communication
• Regulatory compliance and inspection readiness
• Documentation management (CTMS, eTMF, study materials)
• Systems familiarity (EDC, IRT, CTMS, eTMF)

Education

• Bachelor’s Degree or equivalent

Additional Requirements

• There are no travel requirements specified beyond general expectations for global roles; this is a remote position.