Site Management Lead (SML) – Clinical Research (Hybrid)
Company: AbbVie
Function: Research & Development – Clinical Development Operations
Employment Type: Full-Time
Job ID: R00136162
Work Model: Hybrid (Onsite Tuesday–Thursday)
Primary Location: North Chicago, Illinois, USA
Additional Locations: Worcester, MA | Branchburg & Florham Park, NJ | Irvine & South San Francisco, CA
Eligible Regions: Open to U.S. and EU candidates
Experience Required: Minimum 5–7 years
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to discovering and delivering innovative medicines that address serious health conditions. With a strong presence across immunology, oncology, neuroscience, eye care, and aesthetics, AbbVie combines scientific excellence with operational rigor to transform patient lives worldwide.
Job Overview
AbbVie is seeking a Site Management Lead (SML) to provide strategic direction and operational oversight for Clinical Site Management (CSM) activities across global clinical trials. This leadership role is responsible for ensuring the integrity, quality, and timeliness of site-level execution while collaborating closely with Clinical Study Teams, Country Leaders, and cross-functional stakeholders.
Depending on study complexity and geographic scope, the Site Management Lead may serve as the global CSM study strategy lead or manage regional site execution activities, directing site monitors in a matrix environment.
Key Responsibilities
Study-Level Planning & Strategy
Define and lead the global or regional Clinical Site Management strategy across assigned studies
Evaluate study timelines and assumptions to ensure feasibility of CSM deliverables
Develop and maintain the Site Monitoring Plan and Site Engagement Strategy
Align site management resourcing needs with Country Leaders and study milestones
Study Execution & Oversight
Drive site-level execution across the study lifecycle, including site selection, activation, monitoring, engagement, protocol compliance, and site close-out
Ensure study and regional timelines are met with high-quality deliverables
Oversee monitoring activities, ensuring performance tracking, milestone adherence, and issue resolution
Lead CSM deliverables during data snapshots and database lock activities in alignment with data cleaning plans
Risk-Based Quality Management (RBQM)
Proactively identify, assess, and mitigate site-related risks
Contribute to Risk Assessment and Mitigation Plans (RAMPs)
Monitor trends, escalate compliance concerns, and drive continuous improvement initiatives
Inspection Readiness & TMF Management
Ensure Trial Master File (TMF) completeness for all site management documentation
Maintain continuous inspection readiness throughout study start-up to close-out
Support audit and inspection activities as required
Required Qualifications
Bachelor’s degree in a scientific, medical, or life sciences discipline (or equivalent international qualification)
Minimum 5 years of clinical research industry experience, with at least 2 years in site monitoring, clinical operations, or project management
Experience supporting global clinical trials across Phase II and III (Phase I patient studies preferred)
Strong knowledge of ICH-GCP, global regulatory requirements, SOPs, and ethics standards
Proven ability to lead cross-functional teams and influence stakeholders in a matrix organization
Excellent written and verbal communication skills in English
Strong organizational, planning, and problem-solving abilities
Preferred Experience & Skills
Exposure to multiple therapeutic areas and disease indications
End-to-end clinical trial experience from study initiation through close-out
Strong presentation development and delivery skills
Advanced proficiency in Microsoft Office applications (Word, Excel, PowerPoint, OneNote)
Ability to work autonomously while managing complex, fast-paced clinical programs
Work Model & Location
This is a hybrid role requiring onsite presence at AbbVie offices three days per week (Tuesday–Thursday), with flexibility for remote work on remaining days.
Compensation & Benefits (U.S. Locations)
Annual Base Salary Range: USD 106,500 – 202,500, based on location, experience, and internal equity
Comprehensive benefits package including medical, dental, vision insurance, paid time off, holidays, and retirement plans
Eligibility for short-term incentive and bonus programs
Equal Opportunity & Compliance
AbbVie is an equal opportunity employer and is committed to inclusion, diversity, and ethical hiring practices. Reasonable accommodations are available throughout the recruitment process.
Recruitment Fraud Notice
AbbVie does not request payment, bank details, or sensitive personal information during recruitment. Candidates are encouraged to verify all communications and report suspicious activity.
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