Area Site Management Lead

AbbVie - North Chicago, IL

Full-time - Mid Level

North Chicago, IL

1,001-5,000 employees

Chemical Manufacturing

About the position

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.

Responsibilities

• Manage and oversee day-to-day monitoring activities on assigned studies to ensure CSM deliverables are met.
• Proactively communicate and escalate issues, risks, and mitigation plans to Area/Country Leadership and GSML.
• Support planning with Country teams regarding CSM resources in alignment with study deliverables and milestones.
• Manage database lock efforts and serve as the primary point of contact for CRAs for study and site questions.
• Ensure country/area planned timelines are aligned with overall study planning.
• Create and drive recruitment plans for assigned studies within the geographic area.
• Deliver site selection per targets at the country/area level.
• Represent the Area as part of a coordinated study leadership team directed by the GSML.
• Review completed Site Feasibility Questionnaires and ensure adherence to monitoring plans for assigned studies.
• Conduct trending, assessment of risk, and root cause analysis for emerging issues.
• Develop monitoring tools for trials and ensure consistency across the area.
• 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 and protocol deviation specifications.
• Liaise with study-start-up to ensure timely site start-up and recruitment across assigned areas/studies.
• Ensure accuracy and timeliness of TESLA and other systems related to site/country events/milestones.
• Analyze emerging trends and escalate to GSML and Area leadership as appropriate.

Requirements

• Bachelor's Degree or equivalent in a (para)medical or scientific field, 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.
• Experience as a lead CRA or equivalent experience is preferred.
• Experience in multiple therapeutic areas or disease states is highly desired.
• Strong analytical and critical thinking skills to evaluate complex issues and drive decision making.
• Excellent interpersonal skills to build trust and communicate effectively.
• Strong planning, organizing, and prioritization skills to work in a dynamic environment.
• Advanced skills in Microsoft Word, PowerPoint, Excel, and OneNote.

Nice-to-haves

• Experience in managing multiple priorities in a fast-paced environment.
• Ability to create and deliver presentations effectively.

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Paid holidays
• Paid time off
• Vision insurance