Site Management Lead (Hybrid)

Role Summary

The Site Management Lead (SML) provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The role can be the overall CSM functional study strategy leader or manage area site execution activities in collaboration with other SMLs, depending on study size, complexity, and geographic scope. The role collaborates with Clinical Development Operations and other Site Management leaders, serving as a liaison between site monitors, the study strategy leader, and the Clinical Study Team. This role requires onsite work at AbbVie locations with expected onsite days Tuesday, Wednesday, and Thursday each week.

Responsibilities

• Study Level CSM Planning and Strategy: Analyze study timelines and assumptions to confirm CSM deliverables; communicate CSM resource needs with Country Leaders; accountable for study level site monitoring strategy documented in the Site Monitoring Plan; lead Site Engagement Strategy
• Study Execution Accountability and Monitoring Oversight: Maintain study-level and/or area-level timelines; provide timely study information to country-level teams; drive site-level activities including site selection, activation, engagement, protocol adherence, and close out
• Oversee monitoring activities at study/area level in collaboration with other SMLs to ensure quality deliverables, status tracking, and milestone adherence
• Drive CSM deliverables during data snapshots and database locks in alignment with the Data Cleaning Plan; ensure sites are closed per the Site Closure Plan
• Risk-Based Quality Management (RBQM): Proactively identify, evaluate, and mitigate risks; contribute to the Risk Assessment and Mitigation Plan (RAMP); collaborate with other SMLs and stakeholders to address risks and align with study execution; ensure site compliance and analyze trends
• Inspection Readiness and Trial Master File Management (TMF): Provide inputs on expected CSM documents at the study level and drive TMF completeness for CSM artifacts; ensure ongoing CSM Inspection Readiness activities are completed

Qualifications

• Required: Bachelor’s Degree or equivalent degree in (para)medical or scientific field
• Required: Minimum of 5 years of industry clinical research experience; preferred 2 years of monitoring or project management or equivalent on a global study
• Preferred: Exposure in study initiation through completion in multiple phases (Phase II/III, Phase I in patients); experience across multiple therapeutic areas
• Required: Demonstrates core and technical competencies in clinical trials; strong communication and leadership abilities; ability to influence in a matrix environment
• Required: Competence with standard procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
• Required: Strong written and verbal communication skills in English; excellent planning and organizational abilities; ability to thrive in a dynamic environment
• Required: Ability to create and deliver presentations; ability to work autonomously within a matrix team
• Required: Advanced skills in Microsoft Word, PowerPoint, Excel, and OneNote

Education

• Bachelor’s Degree or equivalent in a (para)medical or scientific field

Skills

• Strong communication and leadership capabilities; adept at navigating a matrix organization
• Proficiency in project planning, risk management, and data-driven decision making
• Expertise with Microsoft Office suite (Word, PowerPoint, Excel, OneNote)

Additional Requirements

• Onsite work required: Tuesday, Wednesday, and Thursday each week
• Locations include: Illinois – North Chicago; Massachusetts – Worcester; New Jersey – Branchburg and Florham Park; California – Irvine and South San Francisco