Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com.
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Job Description Purpose: 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.
Function as a liaison and primary contact between CRAs and GSML.
Responsibilities: Manage and oversee day-to-day monitoring activities on assigned study(ies) 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. Proactively communicate and support planning with Country teams (COM / CCOM) the CSM resources in alignment with the study deliverables and milestones. Accountable for creating and driving recruitment plans for their assigned study(ies) within their geographic Area. Review completed Site Feasibility Questionnaires, ensuring adherence to monitoring plans (SEV, STV, on-site/off-site, COV) for assigned study(ies). Conduct trending, assessment of risk, mitigation plans, root cause analysis for issues and emerging issues. Develop monitoring tools for trial, drive implementation and ensure consistency across area. Conduct CRA teleconferences to deliver training and information as required. Liaise with study-start-up to ensure timely site start-up. Ensure issues/observations are entered, escalated, and actioned in a timely manner. Maintain knowledge of ICH/GCP, regulatory requirements, AbbVie SOPs, therapeutic area (protocol, amendments). Qualifications: Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field highly preferred, or equivalent years of experience required. A minimum of 5 – 7 years of industry clinical research experience including 2 years of monitoring or equivalent experience. Prefer candidates that have functioned as a lead CRA/ have equivalent experience. Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust, communicate with influence, clarity, flexibility, and adaptability to changing requirements. Excellent planning, organizing and proactive prioritization skills; ability to work effectively and efficiently in a dynamic, fast-paced environment. Strong ability to create and deliver presentations. Able to work well within a matrix team in a fast-paced environment managing multiple priorities. Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote. Additional Information: AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
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