As a Study Management Associate II, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Study Management Associate II works as a contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of a Study Project Manager and SMA Manager. The Study Management Associate II works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate II is expected to work in accordance with all AbbVie Ways of Working. This is a global role and may be located virtually.
Responsibilities:
- The Study Management Associate II is expected to work as a clinical study contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
- Study-level oversight and contribution to one or more global trials in a cross-functional environment for activities from inception through closure, including but not limited to:
- Supporting 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 the study and regional levels to drive for timely execution of clinical trial(s)
- Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
- Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
- Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing • Ensure inspection readiness and participate in related activities • Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention
- Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
- Protocols, regulatory submissions, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
- CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
- EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight
- Management of investigational product and other associated study supplies • Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors • Support process improvement initiatives or serve as a subject matter expert and/or mentor
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