Senior Clinical Site Strategy Lead

AbbVie; Maidenhead; On-site; GBP 85,000 - 110,000; Full time

Job summary

AbbVie, Maidenhead, UK, is seeking a Sr. SML to lead Clinical Site Management across assigned studies, ensuring integrity, quality and timely delivery of CSM activities from planning to closeout.

You will influence Clinical Development Operations and collaborate with key stakeholders to drive strategic planning, resource management, and site-level execution with accountability for deliverables and timelines.

Qualifications

• Bachelor’s Degree or equivalent OUS degree.
• Industry clinical research experience including monitoring or project management or equivalent experience on a global study.
• Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients).
• 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.
• Ensure study 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 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 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.

Job description

AbbVie, Maidenhead, UK, is seeking a Sr. SML to lead Clinical Site Management across assigned studies, ensuring integrity, quality and timely delivery of CSM activities from planning to closeout.

You will influence Clinical Development Operations and collaborate with key stakeholders to drive strategic planning, resource management, and site-level execution with accountability for deliverables and timelines.