Site Management Lead
AbbVie
August 25, 2026
Remote friendly (Irvine, CA)
United States
$109,500 - $208,500 USD yearly
Clinical Research and Development
Responsibilities:
- Provide direction and operational expertise for Clinical Site Management (CSM) integrity, quality, and timeliness for assigned studies; may serve as overall CSM functional study strategy leader and/or manage area site execution.
- Drive study-level global/area-level CSM deliverables by targeted timelines with allocated resources.
- Analyze study timelines/assumptions to confirm CSM deliverables are feasible; coordinate CSM resource needs with Country Leaders; lead the Site Monitoring Plan and Site Engagement Strategy.
- Maintain study/area timelines across the lifecycle; provide essential information to country teams; drive site activities (selection, activation, engagement, protocol adherence, closeout).
- Oversee monitoring activities to ensure quality deliverables, status tracking, and milestone adherence; align deliverables to Data Cleaning Plan; ensure site closure per Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks; contribute to Risk Assessment and Mitigation Plan (RAMP).
- Collaborate with Clinical Study Team stakeholders to manage risks; ensure compliance, escalate issues, and analyze trends for continuous improvement.
- Provide inputs for expected CSM documents; drive TMF completeness for CSM artifacts.
- Ensure 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 across multiple phases (Phase I in patients; Phase II/III) and multiple therapeutic areas/disease states.
- Strong communication, leadership, planning/organization; influence without authority in a matrix.
- Knowledge of SOPs, ICH, global regulations, ethics, and compliance.
- Advanced MS Word/PowerPoint/Excel/OneNote.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Application instructions: Not specified in the provided text.
- Provide direction and operational expertise for Clinical Site Management (CSM) integrity, quality, and timeliness for assigned studies; may serve as overall CSM functional study strategy leader and/or manage area site execution.
- Drive study-level global/area-level CSM deliverables by targeted timelines with allocated resources.
- Analyze study timelines/assumptions to confirm CSM deliverables are feasible; coordinate CSM resource needs with Country Leaders; lead the Site Monitoring Plan and Site Engagement Strategy.
- Maintain study/area timelines across the lifecycle; provide essential information to country teams; drive site activities (selection, activation, engagement, protocol adherence, closeout).
- Oversee monitoring activities to ensure quality deliverables, status tracking, and milestone adherence; align deliverables to Data Cleaning Plan; ensure site closure per Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks; contribute to Risk Assessment and Mitigation Plan (RAMP).
- Collaborate with Clinical Study Team stakeholders to manage risks; ensure compliance, escalate issues, and analyze trends for continuous improvement.
- Provide inputs for expected CSM documents; drive TMF completeness for CSM artifacts.
- Ensure 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 across multiple phases (Phase I in patients; Phase II/III) and multiple therapeutic areas/disease states.
- Strong communication, leadership, planning/organization; influence without authority in a matrix.
- Knowledge of SOPs, ICH, global regulations, ethics, and compliance.
- Advanced MS Word/PowerPoint/Excel/OneNote.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Application instructions: Not specified in the provided text.