The Sr. SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position is assigned to studies as the overall CSM functional study strategy leader and single point of accountability for study level CSM deliverables from study planning to close out.
Influences and aligns within Clinical Development Operations and other key stakeholders in assigned studies. Accountable for planning and driving study-level CSM strategic planning and completion of deliverables by targeted timelines and with allocated resources for their assigned studies. Directs and coordinates site management activities in collaboration with assigned SMLs managing area site execution activities if applicable.
Accountable for driving overall study level CSM deliverables by targeted timelines with allocated resources for their assigned studies.

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 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, 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.