Purpose:

The SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned to serve as the overall CSM functional study strategy leader and/or can be assigned to manage area site execution activities in collaboration with other assigned SMLs dependent on size, complexity, and geographic scope of assigned studies.
Influences and aligns within Clinical Development Operations, with other assigned Site Management leaders, and key stakeholders in assigned studies. If assigned as the study strategy leader, is a key member of the Clinical Study Team representing CSM globally from study planning to close out. If assigned to area site execution activities, responsible and accountable for directing site monitors in a matrix environment and serve as a liaison and primary contact between site monitors, the study strategy leader, and the Clinical Study Team.
Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for their assigned studies.

Core Responsibilities:

• Study Level CSM Planning and Strategy:
• 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
• Study Execution Accountability and Monitoring Oversight:

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
• Risk-Based Quality Management (RBQM):
• 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
• Inspection Readiness and Trial Master File Management (TMF):
• 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