Responsible for the design and execution of our clinical studies, you will work closely with cross-functional teams, develop study protocols, analyze data, and generate clinical evidence to support regulatory submissions. This individual will collaborate closely with external stakeholders including key opinion leaders and Investigators, and provide support for clinical evidence discussions with regulatory agencies.
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Assist in studies focused on measuring and training cognitive processes, managing studies focused on digital cognitive assessments and training programs. Work with diverse populations and be sensitive to the needs of different people. Strong project management skills are needed to coordinate with team members, monitor progress, and advance research objectives in both remote and in-person settings.
In this role, you will provide unbiased medical guidance to clinical sites and internal and external study operations teams. You will also provide therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management.
As a Principal Biostatistician, you will play a critical role in shaping real-world evidence (RWE) strategies across the organization. You will lead statistical design and analysis for our clinical registry projectβa cornerstone initiative for understanding long-term clinical outcomes. This role partners closely with surgeons, clinical experts, and cross-functional teams to generate high-quality evidence, publish impactful research, and present findings at scientific meetings.
The Senior CRA will enableΒ AbbVieβ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies. Responsibilities: For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
The Study Risk Lead is the risk management subject matter expert for study execution and central monitoring in AbbVieβs end-to-end RBQM modelβa critical pillar required in AbbVieβs mission to be a world-class R&D organization. The Study Risk Lead partners with the cross functional study team and the Central Monitor team. The purpose of the Study Risk Lead is to establish the early detection and intervention framework for study risks, determining what to look for and how to intervene effectively, to enable proactive risk mitigation.