Site Management Lead
AbbVie
August 25, 2026
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Clinical Research and Development
The SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. May serve as overall CSM functional study strategy leader and/or manage area site execution activities in collaboration with other assigned SMLs.
Responsibilities:
- Accountable for driving study-level global and/or area-level CSM deliverables by targeted timelines with allocated resources.
- Analyze study timelines/assumptions to confirm CSM deliverables are feasible; support and communicate CSM resource needs with Country Leaders; set and lead Site Engagement Strategy; own site monitoring strategy in the Site Monitoring Plan.
- Maintain study/area timelines across the lifecycle; drive site-level activities (site selection, activation, engagement, protocol adherence, closeout).
- Oversee monitoring activities to ensure quality deliverables, status tracking, and milestone adherence/acceleration; drive deliverables during data snapshots/database locks aligned to the Data Cleaning Plan; ensure site closure per the Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks; contribute to the Risk Assessment and Mitigation Plan (RAMP).
- Collaborate with Clinical Study Team to manage risks, ensure site compliance, escalate issues, and analyze trends for continuous improvement.
- Provide inputs on expected CSM documents and drive TMF completeness for CSM artifacts.
- Ensure study-level CSM Inspection Readiness activities are completed from study start to close.
Qualifications:
- Bachelor’s degree or equivalent OUS degree in (para)medical or scientific field.
- 5+ years industry clinical research experience, including 2+ years monitoring or project management/global study experience.
- Preferred: exposure from study initiation through completion (Phase I in patients, Phase II/III); multiple therapeutic areas/disease states.
- Strong communication and leadership; influence without authority in a matrix.
- Knowledge of SOPs, ICH, global regulations, ethics and compliance.
- Fluent English; strong planning/organization; able to work team-based and autonomously; presentation skills.
- Advanced Microsoft Word, PowerPoint, Excel, OneNote.
Responsibilities:
- Accountable for driving study-level global and/or area-level CSM deliverables by targeted timelines with allocated resources.
- Analyze study timelines/assumptions to confirm CSM deliverables are feasible; support and communicate CSM resource needs with Country Leaders; set and lead Site Engagement Strategy; own site monitoring strategy in the Site Monitoring Plan.
- Maintain study/area timelines across the lifecycle; drive site-level activities (site selection, activation, engagement, protocol adherence, closeout).
- Oversee monitoring activities to ensure quality deliverables, status tracking, and milestone adherence/acceleration; drive deliverables during data snapshots/database locks aligned to the Data Cleaning Plan; ensure site closure per the Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks; contribute to the Risk Assessment and Mitigation Plan (RAMP).
- Collaborate with Clinical Study Team to manage risks, ensure site compliance, escalate issues, and analyze trends for continuous improvement.
- Provide inputs on expected CSM documents and drive TMF completeness for CSM artifacts.
- Ensure study-level CSM Inspection Readiness activities are completed from study start to close.
Qualifications:
- Bachelor’s degree or equivalent OUS degree in (para)medical or scientific field.
- 5+ years industry clinical research experience, including 2+ years monitoring or project management/global study experience.
- Preferred: exposure from study initiation through completion (Phase I in patients, Phase II/III); multiple therapeutic areas/disease states.
- Strong communication and leadership; influence without authority in a matrix.
- Knowledge of SOPs, ICH, global regulations, ethics and compliance.
- Fluent English; strong planning/organization; able to work team-based and autonomously; presentation skills.
- Advanced Microsoft Word, PowerPoint, Excel, OneNote.