Site Management Lead

AbbVie•North Chicago, IL

21h•$109,500 - $208,500

About The Position

The Site Management Lead (SML) provides direction and operational expertise for the integrity, quality, and timeliness of Clinical Site Management activities in assigned studies. Depending on the size, complexity, and geographic scope of a study, the SML may lead the overall CSM functional study strategy, manage area site execution activities in collaboration with other SMLs, or perform both roles. The SML aligns with Clinical Development Operations, other Site Management leaders, and study stakeholders. As study strategy leader, the SML represents CSM globally on the Clinical Study Team from study planning through closeout. When responsible for area site execution, the SML directs site monitors in a matrix environment and acts as the liaison and primary contact among site monitors, the study strategy leader, and the Clinical Study Team.

Requirements

Bachelor’s degree or equivalent OUS degree, typically in a (para)medical or scientific field.
At least 5 years of industry clinical research experience, including 2 years of monitoring or project management experience, or equivalent experience on a global study.
High level of core and technical competencies demonstrated through management of various components of clinical trials.
Good communication skills and demonstrated leadership abilities, including the ability to influence without authority in a matrix environment.
Competence applying standard business procedures, including Standard Operating Procedures, ICH, global regulations, ethics, and compliance.
Strong written and verbal communication skills, including fluency in English.
Excellent planning and organizational skills and ability to work effectively and efficiently in a dynamic, fast-paced environment.
Ability to work well both within a team and autonomously, with a proactive approach.
Strong ability to create and deliver presentations.
Advanced skills in Microsoft Word, PowerPoint, Excel, and OneNote.

Nice To Haves

Exposure to study initiation through study completion across multiple study phases, including Phase II and III and Phase I in patients.
Experience in multiple therapeutic areas or disease states/indications.

Responsibilities

Drive study-level global and/or area-level CSM deliverables to targeted timelines using allocated resources.
Analyze study timelines and assumptions to confirm that CSM deliverables are feasible.
Communicate CSM resource needs to Country Leaders in alignment with study deliverables and milestones.
Own the study-level site monitoring strategy and document it in the Site Monitoring Plan.
Set and lead the Site Engagement Strategy.
Maintain study-level and/or area-level timelines throughout the study lifecycle.
Provide country-level teams with timely, essential study information to execute milestones.
Drive site-level activities at the study and/or area level, including site selection, activation, engagement, protocol adherence, and closeout.
Oversee monitoring activities with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration where applicable.
Drive CSM deliverables for data snapshots and database locks in alignment with the Data Cleaning Plan.
Ensure sites are closed according to the Site Closure Plan.
Identify, evaluate, and mitigate risks proactively; develop effective action plans and contribute to the Risk Assessment and Mitigation Plan (RAMP).
Collaborate with other SMLs and Clinical Study Team stakeholders to manage risks and align on study execution.
Ensure site compliance, escalate issues, and analyze trends for continuous improvement.
Provide input on expected study-level CSM documents and drive completeness of CSM artifacts in the TMF.
Ensure ongoing study-level CSM inspection-readiness activities are completed from study start through closeout.