AbbVie - North Chicago, IL
posted about 2 months ago
The Area Site Management Lead (ASML) at AbbVie is a pivotal role responsible for overseeing Clinical Site Management (CSM) study deliverables within a designated geographical area. This position requires a strong leader who can direct Clinical Research Associates (CRAs) in a matrix environment, ensuring that all study-related activities are executed efficiently and effectively. The ASML serves as the primary liaison between CRAs and the Global Site Management Lead (GSML), facilitating communication and collaboration to meet project goals. In this role, the ASML will manage day-to-day monitoring activities, ensuring that CSM deliverables are met by tracking project metrics and statuses. Proactive communication is essential, as the ASML will need to escalate issues, risks, and mitigation plans to Area/Country Leadership and the GSML. The ASML will also support planning with country teams to align CSM resources with study deliverables and milestones, and will be accountable for recruitment plans and site selection targets. The ASML will conduct thorough reviews of site feasibility questionnaires and ensure compliance with monitoring plans. They will also be responsible for developing monitoring tools, providing training to CRAs, and ensuring audit readiness at the country and site levels. This role requires a deep understanding of ICH/GCP guidelines, regulatory requirements, and AbbVie SOPs, as well as the ability to analyze trends and contribute to process improvement initiatives. The ASML will work collaboratively across areas and globally, as needed, to ensure the success of clinical trials.