.Job Overview : The Area Site Management Lead is responsible and accountable for directing CRAs in a matrix environment and for driving the successful execution of Clinical Site Management (CSM) study deliverables for their assigned studies within their geographical Area. ASMLs are study experts and provide monitoring expertise and ensure on-time and quality CSM deliverables (data, monitoring plan, SOPs, regulations). Review site and CRA outputs for compliance with protocol and monitoring plans.Primary responsibilities include but are not limited to:Manage and oversee day-to-day monitoring activities on assigned study/studies to ensure CSM deliverables are met by tracking and maintaining project metrics and status of deliverables.Proactively communicate and escalate issues, risks, and mitigation plans to Area/Country Leadership and GSML.Support planning with Country teams (COM / CCOM) regarding CSM resources in alignment with study deliverables and milestones.Support and manage database lock efforts.Act as the primary point of contact for CRAs for study and site questions.Ensure country/area planned/LBEs timelines are aligned with overall study planning.Create and drive recruitment plans for assigned studies within their geographic Area.Deliver site selection per targets at country/area level.Represent Area as part of a coordinated study leadership team directed by the GSML in delivering on-time and on-target quality CSM deliverables.Review completed Site Feasibility Questionnaires, ensuring adherence to monitoring plans.Conduct trending, assessment of risk, mitigation plans, and root cause analysis for issues and emerging issues.Develop monitoring tools for trials, drive implementation, and ensure consistency across areas.Provide monitoring plan training and ongoing non-clinical CRA training.Conduct CRA teleconferences to deliver training and information as required.Collaborate with GSML in reviewing study-specific eCRFs, completion guidelines, protocol deviation specifications, user acceptance testing, etc.Liaise with study-start-up to ensure timely site start-up.Ensure accuracy, completeness, and timeliness of TESLA and other systems.Analyze for emerging trends and escalate to GSML and Area leadership as appropriate.Contribute to ongoing process improvement initiatives within their geographic area.Work across areas or globally depending on site distribution.Serve as an AdaptiV ambassador ensuring implementation and ensuring risk-based thinking on trial.May conduct joint visits with CRAs at challenging sites, as needed.Ensure audit/inspection readiness at country/site level, including TMF completeness.Maintain knowledge of ICH/GCP, regulatory requirements, AbbVie SOPs, therapeutic area (protocol, amendments).Education/Qualifications : Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field highly preferred, or equivalent years of experience required
