AbbVie · 9 hours ago
Site Management Lead (Hybrid)
AbbVie is dedicated to discovering and delivering innovative medicines that address serious health issues. The Site Management Lead (SML) is responsible for providing direction and operational expertise for Clinical Site Management, ensuring the integrity, quality, and timeliness of activities in assigned studies, and driving study-level deliverables.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM
Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones
Accountable for study level site monitoring strategy, documented in Site Monitoring Plan
Accountable to set and lead Site Engagement Strategy
Ensure study-level and/or area-level timelines are maintained across the study lifecycle
Provide timely and essential study information for country-level teams to execute milestones
Drive site-level activities at study level and/or area level, including site selection, activation, site engagement, protocol adherence and close out
Oversee monitoring activities at study and/or area level in collaboration with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable
Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan
Ensure sites are closed per Site Closure Plan
Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP)
Collaborate with other assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution
Ensure site compliance, escalate issues, and analyze trends for continuous improvement
Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts
Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level
Qualification
Required
Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field
A minimum of 5 years of industry clinical research experience and preferred 2 years of monitoring or project management or equivalent experience on a global study
Demonstrates a high level of core and technical competencies through management of various components of clinical trials
Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment
Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance)
Demonstrated good written and verbal communication skills including fluency in English
Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment
Strong ability to create and deliver presentations
Able to work well within a matrix team and autonomously. Thinks proactively
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
Preferred
Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients)
Experience in multiple therapeutic areas or disease state/indications highly desired
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Recent News
2026-01-23
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2026-01-20
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