Global Clinical Site Strategy Lead

Allergan; Northern (KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

AbbVie in the United States seeks an experienced Sr. SML to provide direction and operational expertise for Clinical Site Management (CSM) across assigned studies.

You will be the single point of accountability for study-level CSM deliverables from planning through close-out, coordinating with Clinical Development Operations and other stakeholders. You will influence strategy, drive timelines, and ensure resource alignment, with a focus on risk mitigation, site compliance, and TMF readiness in a

Qualifications

• Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• A minimum of 7 years of industry clinical research experience including 2 years of monitoring or project management or equivalent experience on a global study.
• Minimum 1 year global project management experience.
• 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.
• 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 (SOPs, ICH, Global Regulations, Ethics and Compliance).
• Demonstrated good written and verbal communication skills including fluency in English.

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.
• Drive site-level activities at study level including site selection, activation, site engagement, protocol adherence and close out.
• Oversee monitoring activities at study level in collaboration with 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 assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
• Ensure site compliance, elevate 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.

Skills

Communication

Leadership

Project management

SOP/ICH compliance

English fluency

Teamwork

Organizational skills

Education

Bachelor’s Degree or equivalent

Tools

MS Word

MS Excel

PowerPoint

OneNote

Job description

AbbVie in the United States seeks an experienced Sr. SML to provide direction and operational expertise for Clinical Site Management (CSM) across assigned studies.

You will be the single point of accountability for study-level CSM deliverables from planning through close-out, coordinating with Clinical Development Operations and other stakeholders. You will influence strategy, drive timelines, and ensure resource alignment, with a focus on risk mitigation, site compliance, and TMF readiness in a